Injection device and method of assembly and activation

ABSTRACT

An injector device for injecting or transferring a pharmaceutical product from a pharmaceutical cartridge. The injector device includes an injector body having a side wall having a proximal end portion and a distal end portion, the side wall having an inner surface and an outer surface, the inner surface of the side wall defining a space for receiving at least a portion of a body of a pharmaceutical cartridge therein. One or more retention members are disposed on the outer surface of the body. The injector device further includes a plunger rod having a proximal end portion and a distal end portion, the distal end portion of the plunger rod having a connection member constructed for connection to a connecting member mounted on a piston associated with a cartridge. The plunger rod has one or more receiving members formed about its length. The one or more retention members and the one or more receiving members are constructed to cooperatively retain the plunger rod on the body when the plunger rod is in a first position, and are constructed to cooperatively release the plunger rod from the body when the plunger rod is moved toward the distal end of the body to a second position. The plunger rod further includes a surface for engaging a proximal end of a body of a pharmaceutical cartridge positioned within the body of said injector and for moving a proximal end of a body of a pharmaceutical cartridge distally as the plunger rod is moved from its first position to its second position. Movement of the plunger rod from the first position to the second position releases the plunger rod from the body of the injector and simultaneously activates a pharmaceutical cartridge disposed within the body of said injector.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/749,446 filed on May 16, 2007, which claims priority of U.S.Provisional Patent Application Ser. No. 60/800,769 filed on May 16,2006, both of which are expressly incorporated herein by reference andmade a part hereof.

FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable.

TECHNICAL FIELD

The present invention relates generally to injection systems fordelivering a pharmaceutical product to a patient, and more particularlyto a system for expelling a pharmaceutical product from a cartridge anda method for manufacturing an injection device.

BACKGROUND OF THE INVENTION

Pharmaceutical products are often delivered or transferred through theuse of a syringe or a syringe system. Syringe systems can include aneedle of known construction, thereby enabling direct delivery of thepharmaceutical product directly into a patient, e.g., throughintravenous injection, or through a septum that fluidly seals a portassociated with a tube set that is, or can be, fluidly connected to apatient. Alternatively, the syringe system can be provided with a bluntneedle that is constructed to be inserted through a pre-pierced septumof a tube set. The syringe system can also include a luer fitment (maleor female, locking or not-locking) configured to mate with acomplementary luer fitment for transfer of the pharmaceutical productfrom the syringe system into another medical system, e.g., transfer fromthe syringe to a luer-activated valve associated with a tube set.

Many pharmaceutical products in the market today are provided in anampule or cartridge. These ampules or cartridges can be configured foruse with an injection device or system that is designed to be connectedto the ampules or cartridges such that a medical professional can expelthe pharmaceutical product from the ampule or cartridge for delivery tothe patient or transfer to another medical system. One example of anampule or cartridge is the CARPULE® system sold by Hospira, Inc., theAssignee of this application and the inventions disclosed herein.

U.S. Pat. No. 5,653,698, which is incorporated herein by reference inits entirety, provides detailed insight into the structure and operationof a pharmaceutical cartridge of the type to be used in the presentinvention. The cartridge system disclosed in U.S. Pat. No. 5,653,698includes a cartridge 40 configured to retain a pharmaceutical producttherein. A piston 52 is positioned within the cartridge and fluidlyseals a first, open end of the cylindrical wall 44 of cartridge 40.Piston 52 is movable within cartridge 40 such that it causes thepharmaceutical product contained in the cartridge 40 to be ejected fromthe cartridge as piston 52 is moved toward the second end of thecartridge. A threaded rod 54 is attached to piston 52, the threaded rod54 being constructed to threadably attach to a piston stem 62 which canbe used to facilitate movement of piston 52 within cartridge 40. Thesecond end of cartridge 40 is fluidly sealed by a pierceable diaphragm50 which precludes the ejection of the pharmaceutical product from thecartridge so long as the pierceable diaphragm is intact.

The cartridge system disclosed in U.S. Pat. No. 5,653,698 furtherincludes a hub 20 portion mounted on the second end of cartridge 40. Hub20 includes a snapping sleeve portion 22 that is movably disposed overthe second end of cartridge 40. Hub 20 further includes a needle cannula18 which, when hub 20 and cartridge 40 are moved toward one another,pierces pierceable diaphragm 50 in order to provide for an egresspathway for the pharmaceutical product contained in cartridge 40.

In use, cartridge 40 of the cartridge system disclosed in U.S. Pat. No.5,653,698 is placed into a reusable syringe holder 56 such thatampule/cartridge 40 and snapping sleeve portion 22 of hub 20 arepositioned within the holder 56. Piston stem 62 is then rotatedclockwise to lock ampule 40 within holder 56 and to simultaneously urgeampule 40 forward. Because hub 20 is prevented from moving forward byholder 56, this forward movement of ampule 40 causes ampule 40 and hub20 to move toward one another, causing needle cannula 18 to piercepierceable diaphragm 50, and thereby providing fluid communicationbetween the interior of ampule 40 and the interior of needle cannula 18such that movement of piston 52 will cause fluid to be drawn into orejected from the ampule 40, depending upon the direction of movementimparted to piston 52.

Systems of the type disclosed in U.S. Pat. No. 5,653,698 can be providedwith a variety of structures for delivery or transfer of thepharmaceutical product, including needles for injecting thepharmaceutical product into a patient or for injecting thepharmaceutical product into an add port associated with a drug deliverytube set of known construction. Alternatively, a male or female luerfitting (including both locking and non-locking luer fittings) can beassociated with or attached to the hub for delivery of thepharmaceutical product through a medical device having a complementaryluer fitting, e.g., a luer-activated valve. Also, a blunt tube can beassociated with the hub for delivery of the pharmaceutical product to amedical device having a septum, e.g., a pre-pierced septum, throughwhich the blunt tube can be urged in order to permit the contents of thecartridge to be ejected into the medical device.

Additional examples of injectors constructed for the delivery ofpharmaceutical products from a cartridge can be found in U.S. Pat. Nos.5,447,500; 5,573,514; and Des. 366,698, each of which is incorporatedherein in its entirety. The foregoing examples of the background art areintended to be illustrative and not exclusive.

Accordingly, syringe systems and injectors constructed for the deliveryof pharmaceutical products from a cartridge are well known in the art.While such syringe systems and injectors according to the prior artprovide a number of advantageous features, they nevertheless havecertain limitations. The present invention seeks to overcome certain ofthese limitations and other drawbacks of the prior art, and to providenew features not heretofore available. A full discussion of the featuresand advantages of the present invention is deferred to the followingdetailed description, which proceeds with reference to the accompanyingdrawings.

SUMMARY OF THE INVENTION

The present invention generally provides an injector device for use witha pharmaceutical cartridge. According to one embodiment, the injectordevice includes a syringe or injector body, and a plunger rod. Theplunger rod is fixedly connected to the injector body in a firstposition, and is disassociated from the injector body in a secondposition.

According to another embodiment, the injector device generally comprisesan injector body, a plunger rod, a hub clip and a tamper-evident band.

According to another embodiment, the injector device comprising theinjector body, plunger rod, hub clip and tamper-evident band aremanufactured in a multi-shot mold process.

According to another embodiment the injector body, plunger rod, hingeclip and tamper-evident band are mode of materials that precludemechanical or chemical bonding between adjoining components.

According to one embodiment, the injector body has a side wall havingproximal and distal end portions and inner and outer surfaces. The innersurface of the injector body defines a cavity configured to receive atleast a portion of a pharmaceutical cartridge therein. The injector bodyfurther includes one or more retention members disposed on the outersurface of the body.

According to another embodiment the retention members comprise aprotrusion, such as a tenon, projecting radially outwardly from theouter surface of the injector body. In one embodiment the retentionmembers have a dovetail-type configuration. In such embodiment theportion of the retention member proximal the outer surface of theinjector body has a narrower cross-sectional width, generally beingperpendicular to the longitudinal axis of the injector body, than thecross-sectional width of the portion of the retention member distal theouter surface of the injector body.

According to another embodiment, the retention members engage receiverson the plunger rod. In one embodiment the receivers comprise a matingdovetail-shaped cavity or mortise in the plunger rod.

According to another embodiment, the retention members are connected tothe injector body in the first position of the plunger rod. In a secondposition of the plunger rod, wherein the plunger rod is axiallydisplaced from the first position, however, the retention members aredisassociated from the injector body. In one embodiment, the retentionmembers comprise fracturable posts. In another embodiment the posts havea tab extending transversely therefrom for engagement with the plungerrod.

According to another embodiment, the plunger rod has proximal and distalend portions. The distal end portion of the plunger rod has a connectionmember constructed for connection to a connecting member associated witha piston positioned within the pharmaceutical cartridge. The plunger rodfurther has one or more receiving members between the proximal endportion and the distal end portion for cooperation with the retentionmembers on the injector body.

According to another embodiment, the retention members and the receivingmembers are constructed to cooperatively retain the plunger rod to theinjector body adjacent the outer surface of the injector body when theplunger rod is in a first position. Further, the retention members andthe receiving members are constructed to cooperatively release theplunger rod from the injector body when the plunger rod is transitionedaxially toward the distal end of the injector body to a second position.

According to another embodiment, the receiving members compriseapertures configured to fixedly receive the retention members. In oneembodiment the apertures have resilient members with a flange extendingtherefrom that fixedly engage the tab to prevent reverse movement of theposts.

According to another embodiment, the retention members comprise one ormore wing members spatially disposed on the outer surface of theinjector body. The wing members each have a retaining tab for engagingthe receiving members of the plunger rod. In another embodiment thereceiving members on the plunger rod comprise one or more ledges formating with the wing members.

According to another embodiment, the plunger rod further has a pushingsurface for engaging the cartridge positioned within the cavity of theinjector body. The pushing surface is constructed to move the cartridgebody axially distally as the plunger rod is moved from the firstposition to the second position. Additionally, in one embodimentmovement of the plunger rod from the first position to the secondposition releases the plunger rod from the injector body, and movementof the plunger rod from the first position to the second positionsimultaneously activates the pharmaceutical cartridge.

According to another embodiment, the pushing surface has a flangeextending therefrom to create a cavity which receives a portion of thepharmaceutical cartridge to preclude access to a grommet at a proximalend of the cartridge.

According to another embodiment the pushing surface has a nub projectingtransversely therefrom. The nub precludes access to a grommet at aproximal end of the cartridge. In a preferred embodiment, the nubextends partially into a proximal end portion of the cartridgepositioned within the cavity of the injector body.

According to another embodiment, the distal end portion of the plungerrod has a connection member constructed to attach to a connecting memberassociated with a piston of the pharmaceutical cartridge fortransitioning the plunger of the pharmaceutical cartridge. In oneembodiment the connection member of the plunger rod has threads formedthereon. In such an embodiment the plunger rod can be threadably securedto a connecting member mounted on a piston associated with thecartridge. In an alternate embodiment the connection member of theplunger rod has a snap-fit member constructed to connect by snap fit toa connecting member mounted on a piston associated with a cartridge.

According to another embodiment, the pharmaceutical cartridge has a bodyportion defining an interior space. The interior space is fluidly sealedat a first, proximal end by a piston having a connecting member. Thepharmaceutical cartridge is further fluidly sealed at a second, distalend by a pierceable diaphragm. The pharmaceutical cartridge furtherincludes a hub slidably mounted on a distal end portion of the bodyportion. The hub includes a piercing member constructed to pierce thepierceable diaphragm sealing the second, distal end of the cartridgebody portion. The cartridge is slidable relative to the hub between afirst, inactivated position in which the piercing member is positioneddistal to the pierceable diaphragm and in which the pierceable diaphragmfluidly seals the cartridge, and a second, activated position in whichthe piercing member is disposed through the pierceable diaphragm andwherein a flow channel defined by the piercing member is in fluidcommunication with the interior space defined by the pharmaceuticalcartridge, thereby allowing the contents of the interior space to beejected from the cartridge through the piercing member by moving thepiston toward the distal end portion of the cartridge body.

According to another embodiment, the hub is fixed in place in the cavityof the injector body with a clip. In one embodiment, the clip hasprojections that extend through openings in the side wall of theinjector body to engage the hub to prevent axial and radial movement ofthe hub.

According to another embodiment, the clip is rotatedly connected to theinjector body, and the clip is rotatable from a first position whereinthe clip is positioned outside the cavity of the injector body, and asecond position wherein a portion of the clip is positioned within thecavity of the injector body to retain the hub of the pharmaceuticalcartridge.

According to another embodiment, the injector body further comprisestransverse finger grips extending from the proximal end portion of theinjector body. Additionally, the injector body also has grip openings inthe sidewall of the injector body. The grip openings are positioned onthe distal end side of finger grips. The grip openings assist the userin activating the cartridge and dispensing the pharmaceutical productfrom the cartridge. The grip openings also allow the finger grips tohave a decreased size.

According to another embodiment, the injector body is preferably clearor transparent, allowing the cartridge inserted into the cavity of theinjector body to be visible through the sidewall of the injector body.In this manner, a bar code on the outer wall of the cartridge may bevisible through the sidewall of the injector body and can be scannedthrough the sidewall when the pharmaceutical cartridge is seated in theinjector body.

According to another embodiment, a combination of a pharmaceuticalcartridge and an injector is provided. The combination includes acartridge body defining an interior space for retaining a pharmaceuticalproduct. A piston is positioned within the interior space defined by thecartridge body at a proximal end portion of the cartridge body. Thepiston fluidly seals a proximal end of the cartridge body portion. Thepiston has a connecting member associated therewith. The cartridge alsohas a pierceable diaphragm fluidly sealing a distal end portion of thecartridge body. The cartridge further includes a hub slidably mounted onthe distal end portion of the cartridge body, the hub including apiercing member constructed to pierce the pierceable diaphragm. Thepiercing member defines a flow channel. The cartridge is slidablymovable between a first, inactivated position in which the piercingmember is disposed external to the interior space defined by thecartridge body portion and a second, activated position in which thepiercing member is disposed through the pierceable diaphragm and inwhich the flow channel defined by the piercing member is in fluidcommunication with the interior space defined by the cartridge body,such that a pharmaceutical product disposed in the interior spacedefined by the cartridge body can be ejected through the flow channeldefined by the piercing member by moving the piston toward the distalend portion of the pharmaceutical cartridge. The injector of thecombination includes an injector body having a side wall having aproximal end portion and a distal end portion. The side wall has aninner surface and an outer surface, the inner surface of the side walldefining a space for receiving at least a portion of the cartridge bodyof the pharmaceutical cartridge therein. Preferably, though notnecessary, either a clip or a portion of the injector body isconstructed to prevent movement of the hub of the pharmaceuticalcartridge in a distal direction when the pharmaceutical cartridge isdisposed within the injector body. The injector also has one or moreretention members disposed on the outer surface of the injector body.The plunger comprises a plunger rod having a proximal end portion and adistal end portion. The distal end portion of the plunger rod has aconnection member constructed to attach to the connecting memberassociated with the piston of the pharmaceutical cartridge. The plungerrod has one or more engagement members formed along its length. Invarious embodiments the engagement members comprise surfaces,projections or receivers. The one or more engagement members and the oneor more retention members are constructed to cooperatively retain theplunger rod on the injector body when the plunger rod is in a firstposition, and the one or more engagement members and the one or moreretention members are constructed to cooperatively release the plungerrod from the body when the plunger rod is moved toward the distal end ofthe injector body to a second position. In another embodiment theplunger rod further includes a surface for engaging the proximal endportion of the cartridge body positioned within the injector body. Thesurface of the plunger rod is configured to move the proximal endportion of the cartridge body distally as the plunger rod is moved fromthe first position to its second position, whereby movement of theplunger rod from the first position to the second position releases theplunger rod from the injector body, and whereby movement of the plungerrod from the first position to the second position simultaneouslyactivates the pharmaceutical cartridge. In this combination, at least aportion of the cartridge body is disposed within the injector body.

According to another embodiment, the one or more engagement surfacesformed along the length of the plunger rod are defined by a ledge. Inone possible configuration of this alternative embodiment, the ledgeincludes notches spaced apart from each other that correspond tocomplementary retaining tabs provided on the injector body. To attachthe plunger rod to the injector body, the plunger rod is placed over thewings with the notches aligned with the retaining tabs. The plunger rodis then moved proximally along the injector body so as to engage theledge with the retaining tabs. To release the injector rod, the injectorrod is moved distally relative to the injector body so as to place thenotches in position opposite the retaining tabs on the wings. Theinjector rod can then be lifted from the injector body and the distalend of the plunger rod attached to a connecting member on a pistonpositioned with the pharmaceutical cartridge. The distal movement of theinjector rod relative to the injector body also causes an engagementsurface of the injector rod to move a proximal end portion of apharmaceutical cartridge distally, thereby simultaneously activating thepharmaceutical cartridge.

According to another embodiment, the injector system has a visualindicator to indicate when the plunger rod has been manipulated topotentially compromise the integrity of the injector system. In oneembodiment the visual indicator comprises a tamper-evident band.

According to another embodiment, the tamper-evident band has a firstannular portion secured to the injector body, and a second portionsecured to the plunger rod. The second portion secured to the plungerrod has a notched area to provide a fracture zone. Upon movement of theplunger rod with respect to the injector body the band will fracture atthe fracture zone to provide a visual indication that the integrity ofthe system has been compromised.

Other features and advantages of the invention will be apparent from thefollowing specification taken in conjunction with the followingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Example embodiments are illustrated in referenced figures of thedrawings. It is intended that the embodiments and figures disclosedherein are to be considered illustrative rather than restrictive.

FIG. 1A is an isometric view of an injection device having an ampouleholder body receiving an ampoule and a rod attached to and carried bythe body;

FIG. 1B is a side view of the injection device of FIG. 1A;

FIG. 1C is a bottom view of the injection device of FIG. 1A;

FIG. 2A is a top view of a body of the injection device of FIG. 1A;

FIG. 2B is a cross-sectional view of the body of FIG. 2A;

FIG. 3A is a top view of a plunger rod of FIG. 1A;

FIG. 3B is a side view of the plunger rod of FIG. 3A; and

FIG. 4A is a cross-sectional view of the injection device of FIG. 1Aprior to activation of the ampoule;

FIG. 4B is a cross-sectional view of the injection device of FIG. 1after activation of the ampoule;

FIG. 5 is a side view of the injection device of FIG. 1A with theplunger rod attached to the ampoule, the injection device ready fordelivery of a pharmaceutical product contained within the ampoule;

FIG. 6A is an isometric view of a second embodiment of the plunger rodin which the plunger rod has a different attachment mechanism forattaching the plunger rod to the ampoule plunger;

FIG. 6B is a cross-sectional view of the ampoule plunger attached to theplunger rod of FIG. 6A;

FIG. 7A is a top view of one embodiment of a plunger rod;

FIG. 7B is a side view of one embodiment of a plunger rod;

FIG. 7C is a bottom view of one embodiment of a plunger rod;

FIG. 7D is a cross-sectional view of one embodiment of a plunger rod;

FIG. 7E is a view of a proximal end portion of one embodiment of aplunger rod;

FIG. 7F is a cross-sectional view of one embodiment of a proximal endportion of a plunger rod;

FIG. 8A is a top view of one embodiment of an injector system with theplunger rod attached to the plunger of the pharmaceutical cartridge;

FIG. 8B is a side view of one embodiment of an injector system with theplunger rod attached to the plunger of the pharmaceutical cartridge;

FIG. 8C is a bottom view of one embodiment of an injector system withthe plunger rod attached to the plunger of the pharmaceutical cartridge;

FIG. 8D is a side, cross-sectional view of an injector system inaccordance with the present invention with the plunger rod attached tothe plunger of the pharmaceutical cartridge;

FIG. 8E is a cross-sectional view of one embodiment of an injectorsystem with the plunger rod attached to the plunger of thepharmaceutical cartridge;

FIG. 8F is a cross-sectional view of one embodiment of a cartridge bodyand a hub of a pharmaceutical cartridge;

FIG. 9A is a top view of one embodiment of an injector system after theplunger rod and plunger have been moved distally in order to ejectpharmaceutical product from the pharmaceutical cartridge;

FIG. 9B is a side view of one embodiment of an injector system after theplunger rod and plunger have been moved distally in order to ejectpharmaceutical product from the pharmaceutical cartridge;

FIG. 9C is a bottom view of one embodiment of an injector system afterthe plunger rod and plunger have been moved distally in order to ejectpharmaceutical product from the pharmaceutical cartridge;

FIG. 10A is a cross-sectional side view of one embodiment of an injectorsystem after the plunger rod and plunger have been moved distally inorder to eject pharmaceutical product from the pharmaceutical cartridge;

FIG. 10B is a cross-sectional side view of one embodiment of an injectorsystem after the plunger rod and plunger have been moved distally inorder to eject pharmaceutical product from the pharmaceutical cartridge;

FIG. 10C is an enlarged cross-sectional view of one embodiment of theinjector system after the plunger rod and plunger have been moveddistally in order to eject pharmaceutical product from thepharmaceutical cartridge;

FIG. 10D is a front end view of an embodiment of the injector systemwithout a plunger rod;

FIG. 10E is a cross-sectional end view an embodiment of the injectorsystem of FIG. 10D;

FIG. 10F is a rear end view of the injector system of FIG. 10D;

FIG. 11A is a top view of one embodiment of an injector system prior toremoval of the plunger rod from the exterior surface of the injectorbody;

FIG. 11B is a side view of one embodiment of an injector system prior toremoval of the plunger rod from the exterior surface of the injectorbody;

FIG. 11C is a bottom view of one embodiment of an injector system priorto removal of the plunger rod from the exterior surface of the injectorbody;

FIG. 11D is a bottom cross-sectional view of one embodiment of theinjector system prior to activation of the pharmaceutical cartridge;

FIG. 11E is a side cross-sectional view of one embodiment of theinjector system prior to activation of the pharmaceutical cartridge;

FIG. 11F is an enlarged partial cross-sectional view of one embodimentof the hub of the injector system prior to activation of thepharmaceutical cartridge;

FIG. 11G is a cross-sectional end view of an embodiment of the injectorsystem with a plunger rod;

FIG. 11H is a front end view an embodiment of the injector system ofFIG. 11G;

FIG. 11I is a rear end view of the injector system of FIG. 11G;

FIG. 12A is a detailed cross-sectional drawing of one embodiment of topand bottom mold cavities used in connection with the injector system;

FIG. 12B is a detailed cross-sectional drawing of one embodiment of topand bottom mold cavities used in connection with the injector system;

FIG. 12C is an end view of the top and bottom mold cavities used inconnection with the injector system;

FIG. 12D is an end view of the top and bottom mold cavities used inconnection with the injector system;

FIG. 12E is a side view of the top and bottom mold cavities used inconnection with the injector system;

FIG. 12F is an end view of the top and bottom mold cavities used inconnection with the injector system;

FIG. 13 is a perspective view of another embodiment of the injectorsystem;

FIG. 14 is an exploded perspective view of the injector system of FIG.13;

FIG. 15 is a side elevation view of the injector system of FIG. 13;

FIG. 16 is a side cross-sectional view about line 16-16 of FIG. 19;

FIG. 17 is a top plan view of the injector system of FIG. 15;

FIG. 18 is an end elevation view of the injector system of FIG. 15;

FIG. 19 is a front elevation view of the injector system of FIG. 15;

FIG. 20 is a cross-sectional view about line 20-20 of FIG. 15;

FIG. 21 is a partial enlarged view of the retainer post of the injectorsystem of FIG. 16;

FIG. 22 is a cross-sectional view about line 22-22 of FIG. 15;

FIG. 23 a is a side elevation view of one embodiment of the injectorbody of the injector system of FIG. 13;

FIG. 23 b is a partial enlarged view of one embodiment of a retainerpost of the injector body of FIG. 23 a;

FIG. 24 is a top view of the injector body of FIG. 23 a;

FIG. 25 is a side elevation view of one embodiment of a plunger rod forthe injector system of FIG. 13;

FIG. 26 is a cross-sectional elevation view about line 26-26 of FIG. 28;

FIG. 27 is a partial enlarged view of one embodiment of a receiveraperture of the plunger rod of FIG. 25;

FIG. 28 is a top view of the plunger rod of FIG. 25;

FIG. 29 is a bottom view of the plunger rod of FIG. 25;

FIG. 30 is an end elevation view of the plunger rod of FIG. 25;

FIG. 31 is a cross-sectional view of one embodiment of the injectorsystem in the activated position;

FIG. 32 is a cross-sectional view of one embodiment of the injectorsystem with the plunger rod connected to the plunger;

FIG. 33 is a perspective view of another embodiment of the injectorsystem;

FIG. 34 is an exploded perspective view of the injector system of FIG.33;

FIG. 35 is a side elevation view of the injector system of FIG. 33;

FIG. 36 is a top plan view of the injector system of FIG. 33;

FIG. 37 is a cross-sectional view about line 37-37 of FIG. 36;

FIG. 38 is a front elevation view of the injector system without apharmaceutical cartridge inserted therein, and with the clip rotatedaway from the injector body;

FIG. 39 is a first end elevation view of the injector system of FIG. 38;

FIG. 40 is a second end elevation view of the injector system of FIG.38, taken from the plunger end of the injector system;

FIG. 41 is a top view of the injector system of FIG. 38;

FIG. 42 is a side elevation view of the opposing side of the injectorsystem to that of FIG. 38;

FIG. 43 is a cross-sectional view about line 43-43 of FIG. 41;

FIG. 44 is a cross-sectional view about line 44-44 of FIG. 38,illustrating the tamper evident band;

FIG. 45 is a cross-sectional view about line 45-45 of FIG. 38,illustrating the connection of the clip to the injector body;

FIG. 46 is a cross-sectional view about line 46-46 of FIG. 38,illustrating the connection between the plunger rod and the injectorbody;

FIG. 47 is a perspective view of another embodiment of the injector bodyfor use with the injector system of FIG. 38;

FIG. 48 is a side elevation view of the injector body of FIG. 47;

FIG. 49 is a bottom view of the injector body of FIG. 47;

FIG. 50 is an end elevation view of the injector body of FIG. 47;

FIG. 51 is a perspective view of another embodiment of the plunger rodfor use with the system of FIG. 38;

FIG. 52 is a top view of the plunger rod of FIG. 51;

FIG. 53 is a cross-sectional view about line 53-53 of FIG. 52;

FIG. 54 is a side elevation view of the plunger rod of FIG. 51;

FIG. 55 is an end view of the plunger rod of FIG. 51;

FIG. 56 is a bottom view of the plunger rod of FIG. 51;

DETAILED DESCRIPTION

Referring now to FIGS. 1A-1C, an injector device 100 is illustratedcomprising an injector body 105 for receiving and holding apharmaceutical cartridge or ampule 155 containing a pharmaceuticalproduct. As depicted in these figures, plunger rod 130 is mounted oninjector body 105. As discussed in detail herein, plunger rod 130 iscarried on the body 105 prior to activation of pharmaceutical cartridge155. The body 105 includes a side wall 110 having an outer surface 115and an inner surface 120. Although side wall 110 is depicted in theaccompanying figures as being cylindrical in shape, it will beappreciated that the shape of side wall 110 can be varied based upon theshape of the pharmaceutical cartridge 155 to be used therewith. Innersurface 120 of side wall 110 defines a region or space 125 for receivingat least a portion of cartridge 155 therein. Injector body 105 has aproximal end portion 106 and a distal end portion 107. Plunger rod 130has a proximal end portion 131 and a distal end portion 132. Cartridge155 has a proximal end portion 156 and a distal end portion 157.

In one embodiment of the present invention depicted in the accompanyingfigures, injector body 105 is depicted as having a semi-circularcross-sectional configuration. Side wall 110 of injector body 105defines a gap 111 along a length thereof. In the depicted embodiment ofthe present invention, gap 111 is sized such that pharmaceuticalcartridge 155 can be inserted into side wall 110 of injector body 105through gap 111. It will be appreciated that side wall 10 can beconstructed of a flexible, resilient material such as plastic or metalsuch that pharmaceutical cartridge 155 can be inserted into side wall110 through gap 111 despite the fact that the width of gap 111 is lessthan the overall diameter of pharmaceutical cartridge. In this way, sidewall 10 of injector body 105 can be manufactured as a single piece. Inan alternative embodiment, side wall 110 can be formed by two or morepieces connected by a hinge member, or by a living hinge, which enablesthe two or more pieces to be moved away from each other in order toenable pharmaceutical cartridge 155 to be inserted into side wall 110.

It will be appreciated that other methods for placing pharmaceuticalcartridge 155 into side wall 110 can be employed and that side wall 110need not have a gap 111 for allowing placement of the pharmaceuticalcartridge 155 into side wall 110. For example, it is possible toconstruct side wall 110 such that pharmaceutical cartridge 155 isinserted therein from either the proximal or distal end of side wall 10.In such a configuration, retention portion 185 (discussed in detailbelow) will need to be configured such that pharmaceutical cartridge 155can be slid therethrough, for example, by way of diametrically enlargingretention portion 185 or opening retention portion 185 as pharmaceuticalcartridge 155 is slid therethrough, and such that retention portion 185will subsequently interact with pharmaceutical cartridge 155 so as toprevent relative distal movement of hub 20 of pharmaceutical cartridge155, as discussed in detail below. In one embodiment, gap 111 could beformed only through side wall 110 only adjacent to retention portion 185of injector body 105, thereby allowing for the required diametricalenlargement of retention portion 185 as pharmaceutical cartridge 155 ispositioned within side wall 110 of injector body 105.

As depicted in FIGS. 2A and 2B, injector body 105 includes one or moreretention members 135 positioned on outer surface 115 injector body 105.In the embodiment of the present invention depicted in the accompanyingdrawings, retention members 135 are in the form of retaining wings 136disposed on and projecting outwardly from outer surface 115 of side wall10. Each of the wings 136 includes a respective retaining tab 137.Retaining tabs 137 are used to engage one or more complementaryengagement surfaces 133 of plunger rod 130 to releasably attach plungerrod 130 to outer surface 115 of injector body 105. Said complementaryengagement surfaces 133 are also defined as receiving members herein.

In order to enhance the retention of plunger rod 130 by each ofretention members 135, each of engagement surfaces 133 includes aradially enlarged portion 134, as depicted in FIG. 7D. It will beappreciated that the presence of radially enlarged portion 134 willenhance the frictional force with which retention members 135 andplunger rod engagement surfaces 133 interact, thereby improving theretention force with which plunger rod 130 is held on outer surface 115of injector body 105.

In the embodiments of the present invention depicted in the accompanyingfigures, injector body 105 and plunger rod 130 are depicted as separatepieces. These pieces can be injection molded or formed using a varietyof other known tooling techniques. It will be appreciated that injectorbody 105 and plunger rod 130 can be unitarily injection molded withoutdeparting from the intended spirit and scope of the present invention.

In one embodiment of the present invention, plunger rod 130 includesledge 138 running along the length thereof. Ledge 138 is constructed tocooperate with retention members 135, particularly retention tabs 137,to releasably attach plunger rod 130 to injector body 105. Ledge 138includes notches 140 defined therein along its length. When plunger rod130 is positioned axially relative to injector body 105 such thatnotches 140 are aligned with retaining tabs 137 on wings 136 ofretention members 135, plunger rod 130 can be moved radially relative toinjector body 105 without physical contact between ledge 138 andretention tabs 137. That is, when notches 140 are aligned with retainingtabs 137, plunger rod 130 can be removed from injector body 105 orplunger rod 130 can be placed in a position for attachment to injectorbody 105 because the width of ledge 138 at notches 140 is less than thespacing between tabs 137. When plunger rod 130 is positioned axiallyrelative to injector body 105 such that notches 140 are not aligned withretaining tabs 137 on wings 136 of retention members 135, plunger rod130 cannot be moved radially relative to injector body because the widthof ledge 138 is greater than the spacing between tabs 137.

As depicted in FIG. 3B, ramp portions 141 provide a gradual transitionbetween the width of ledge 138 at notches 140 and the width of ledge 138at its broadest along the length of ledge 138. It will be appreciatedthat ramp portions 141 facilitate the attachment and release of plungerrod 130 from injector body 105. Although ramp portions 141 are depictedin the accompanying figures as having a constantly changing diameteralong their length, it will be appreciated that ramp portions 141 canhave other forms so long as they facilitate attachment and release ofplunger rod 130. Ramp portions 141 can also be eliminated, if desired.

Plunger rod 130 is attached to injector body 105 by placing plunger rod130 over injector body 105 and aligning notches 140 with retaining tabs137 on wings 136 and passing retaining tabs 137 through notches 140. Inthis position, radially enlarged portion 134 of plunger rod 130, whichis located adjacent to notch 140, is positioned between wings 136 anddoes not engage injector body 105. Plunger rod 130 is next movedproximally relative to injector body 105, thereby causing ledge 138 tobe positioned radially inwardly (beneath) retention tabs 137. As ledge138 moves beneath retention tabs 137, radially enlarged portion 134 ofplunger rod 130 comes into engagement with outer surface 115 of injectorbody 105, thereby causing plunger rod 130 to move radially outwardly bya distance substantially equal to the thickness of radially enlargedportion 134. This radially outward movement causes ledge 138 to bebrought into contact with the underside of retention tabs 137, therebyproviding a frictional fit between retention tabs 137 and ledge 138.

Although the injector device 100 of the present invention is depicted inthe accompanying figures as including two retention members 135, e.g.,two wings 136 having retention tabs 137, it will be appreciated that asingle retention member 135 can be used to secure plunger rod 130 toouter surface 115 of side wall 110 of injector body 105. Further, itwill be appreciated that more than two retention members 135 can be usedto secure plunger rod 130 to outer surface 115 of side wall 110 ofinjector body 105. Similarly, the details of the construction ofretention members 135 set forth herein are not intended to be limited tothe wing and retention tab depicted in the accompanying drawings. One ofordinary skill in the art will recognize that various modifications canbe made to the number and configuration of retention members 135 withoutdeparting from the spirit and scope of the present invention. In short,the accompanying figures are intended to be illustrative, not limiting,with respect to the configuration and number of retention member 135 ofthe present invention.

As depicted in FIGS. 1A-1C, injector body 105 includes finger grips 145.Finger grips 145 are configured such that a medical professional usinginjector device 100 of the present invention will engage them withhis/her index and middle fingers during normal use. In the embodiment ofthe present invention depicted in the accompanying figures, finger grips145 are convex on a distal side of finger grips 145 and concave on aproximal side of finger grips 145. It will be appreciated that the sizeand shape of finger grips 145 can be modified without departing from thescope of the present invention.

Pushing member 150 is provided on proximal end portion 131 of plungerrod 130. Pushing member 150 includes a proximal surface 151 that isconstructed for engagement with a medical professional's thumb. In use,a medical professional will grasp injector body 105 such that his/herindex and middle fingers are in contact with a distal surface of fingergrips 145 and such that his/her thumb is in contact with proximalsurface 151 of pushing member 150.

Pushing member 150 also includes a surface for pushing 152 which isconstructed to engage proximal end portion 156 of pharmaceuticalcartridge 155 and to urge proximal end portion 156 of pharmaceuticalcartridge distally as a medical professional squeezes his/her index andmiddle fingers towards his/her thumb. The importance of surface forpushing 152 will be described in greater detail later in thisspecification.

Injector body 105 can be provided separately from pharmaceuticalcartridge 155 such that a medical professional, e.g., a pharmacist,inserts pharmaceutical cartridge 155 into injector body 105 immediatelyprior to use. Alternatively, injector body 105 and pharmaceuticalcartridge 155 can be pre-assembled by a manufacturer or assembler andsupplied in combination to medical professionals.

Pharmaceutical cartridge 155 used in conjunction with the presentinvention can have a variety of configurations. In one embodiment,pharmaceutical cartridge 155 is constructed in the manner described inU.S. Pat. No. 5,653,698 which has been incorporated herein by reference.Using many of the lead numbers set forth in U.S. Pat. No. 5,653,698,FIG. 1C depicts the details of pharmaceutical cartridge 155. Cartridge155 is constructed to retain a pharmaceutical product within an interiorspace 40 defined by cartridge 155. Piston/plunger 52 is slidablypositioned within the interior space 40 at proximal end portion 156 ofpharmaceutical cartridge 155. Piston/plunger 52 fluidly seals proximalend portion 156 of pharmaceutical cartridge 155. A connection member160, e.g., threaded rod, is attached to piston/plunger 52 such that itis accessible from the exterior of cartridge 155. Connection member 160can have a variety of configurations, including that of a threaded rodconstructed to engage a plunger rod having complementary threads formedthereon. Alternatively, connection member 160 can be a memberconstructed to provide a snap fit with a complementary connecting memberformed on a plunger rod. Other configurations providing locking orfrictional connections between connection member 160 and a complementarymember on a plunger rod can also be used.

Distal end portion 157 of the cavity 40 of the cartridge 155 is fluidlysealed by pierceable diaphragm 50, as depicted in FIG. 4A. Pierceablediaphragm 50 can be constructed of a variety of known materials,including elastomeric materials that do not core when a piercing memberis passed therethrough. Hub 20 is slidably mounted on cartridge 40 atdistal end portion 157 of pharmaceutical cartridge 155. Hub 20 includesa piercing member (or needle cannula) 18 which is constructed to piercepierceable diaphragm 50. Hub 20 is slidable between a first, inactivatedposition in which piercing member 18 is positioned outside of cartridge155 and distally of pierceable diaphragm 50, and a second, activatedposition in which piercing member is disposed through pierceablediaphragm 50 and in which interior lumen 165 defined by piercing member18 is in fluid contact with the contents in the cavity 40 of cartridge155, thereby providing a pathway for the egress of fluids from cartridge155 through piercing member 18 in response to pressure applied whenpiston/plunger 52 is moved distally.

Hub 20 includes a connecting portion 170 which is configured to deliverthe pharmaceutical product contained in pharmaceutical cartridge 155 toa patient or to another medical apparatus, e.g., a tube set configuredto deliver pharmaceutical products to a patient. As depicted in FIG. 4A,connection portion 170 is a threaded luer member constructed to connectwith a complementary luer member. It will be appreciated that connectionportion 170 can have a variety of configurations, including: (i) ahypodermic needle for delivery of pharmaceutical products directly to apatient or for delivery through a pierceable septum, e.g., a pierceableseptum associated with an add port of a tube set or an add port of aflexible pharmaceutical container; (ii) a blunt needle for delivery ofpharmaceutical products from pharmaceutical cartridge 155 to a medicaldevice having the capability of receiving a pharmaceutical product froma blunt needle, e.g., a pre-slit elastomeric seal on a tube set or aflexible pharmaceutical container; (iii) threaded luer; and/or (iv) anunthreaded luer. Cap member 180 can be provided in order to coverconnector 170 when injector device 100 of the present invention is notin use.

Hub 20 includes a necked-down portion 175, as depicted in FIG. 4A. Asdepicted in FIG. 8F, necked-down portion 175 of hub 20 is constructed tobe positioned within retention portion 185 of side wall 110 at distalend portion 107 of injector body 105. When pharmaceutical cartridge 155is positioned within side wall 110, necked-down portion 175 of hub 20 ispositioned within retention portion 185. Retention portion 185 of sidewall 10 precludes distal movement of hub 20. As depicted in theaccompanying figures, a portion of hub 20 extends beyond side wall 10 ofinjector body 105 such that not all of pharmaceutical cartridge 155 ispositioned within side wall 10 of injector body 105.

In order to use injector device 100 of the present invention, a medicalprofessional will engage finger grips 145 with his/her index and middlefingers and will engage proximal surface 151 of plunger push surface 150with his/her thumb. By squeezing his/her thumb and fingers together,plunger push surface 150 and finger grips 145 are moved closer to oneanother. Also by squeezing his/her thumb and fingers together, surfacefor pushing 152 applies a distal force on proximal end portion 156 ofpharmaceutical cartridge 155. However, because retention portion 185 ofside wall 110 precludes distal movement of hub 20, the application of adistally directed force on proximal end portion 156 of pharmaceuticalcartridge 155 causes pharmaceutical cartridge 155 to move from itsfirst, inactivated position toward its second, activated position. Thesqueezing force also causes plunger rod 130 to move distally relative toinjector body 105 from its first, engaged position in which one or morenotches 140 in ledge 138 are not aligned with the one or more retentiontabs 137 of retention member(s) 135 to its second, released position inwhich one or more notches 140 in ledge 137 are aligned with the one ormore retention tabs 137 of retention member(s) 135. In operation,pharmaceutical cartridge 155 is in its second, activated position whenplunger rod 130 is in its second, released position.

Next, plunger rod 130 is removed from the exterior surface 110 of theinjector body 105 and is positioned such that distal end portion 132 isadjacent to connection member 160 on piston/plunger 52. Where connectionmember 160 is a threaded member, a complementary connection member 190having complementary threads is provided on distal end portion 132 ofplunger rod 130 such that plunger rod 130 can be threadably attached toconnection member 160 on piston/plunger 52, thereby enabling a user tomove piston/plunger 52 proximally and/or distally through theapplication of proximally and/or distally directed forces to plungerpush surface 150 and/or to plunger rod 130. As discussed above,connection members 160 and 190 can have a variety of configurations solong as they provide the desired attachment of plunger rod 130 topiston/plunger 52. For example, connection members 160 and 190 can beconstructed to provide a friction or snap fit therebetween. Otherconfigurations of connection members 160 and 190 will be readilyappreciated by persons of ordinary skill in the art of the presentinvention.

After plunger rod 130 has been connected to piston/plunger 52 usingcomplementary connection members 160, 190, a pharmaceutical productcontained in pharmaceutical cartridge 155 can be delivered to a patientor transferred to another medical device by the application of adistally-directed force to plunger rod 130, e.g., through theapplication of a distally directed force to proximal surface 151 ofplunger push surface 150. If desired, fluids can be aspirated intopharmaceutical cartridge at any time through the application of aproximally directed force to plunger push surface 150.

In most cases it will be preferable to construct pharmaceuticalcartridge 155 from known glass materials due to the relative inactivitybetween glass and most pharmaceutical products. However, it will beappreciated that in certain cases it may be appropriate or necessary touse non-glass materials due to the possible interaction between thepharmaceutical product to be contained in pharmaceutical cartridge 155and the material from which pharmaceutical cartridge 155 is constructed.

Injector body 105, including side wall 10, and plunger rod 130 can beconstructed from a variety of known materials, including metals,plastics, and various known composites. In order to minimize cost,plastic may be preferable. A variety of known plastic materialsproviding the requisite rigidity and other performance characteristicscan be used in conjunction with the present invention. Side wall 110 andplunger rod 130 need not be constructed of the same material.

In one embodiment of the present invention in which plunger rod 130 isconstructed of a plastic material, connection member 190 includes athreaded recess formed on distal end portion 132 of plunger rod 130. Inthis embodiment, plunger rod 130 can be manufactured using a variety ofknown injection molding techniques. For example, the entirety of plungerrod 130 can be injection molded while a male threaded form is positionedat the distal end of the mold. The male threaded member in the mold willcreate a complementary female threaded recess in the distal end of themolded part. However, this approach to injection molding plunger rod 130will require that the male threaded member be removed from the moldedpart by imparting relative rotational movement between the molded partand the male threaded member. This process can be time-consuming andrequire complex tooling when large volumes of plunger rods 130 areinjection molded at high speeds.

In an alternative technique for forming plunger rods 130 havingconnection members 190 in the form of threaded recesses, a new injectionmolding technique has been developed. In this technique, a mold 200,depicted in FIGS. 12A-12G, is provided. Mold 200 defines all of theabove-described features of plunger rod 130 (e.g., engagement surfaces133, radially enlarged portion 134, ledge 138, and plunger push surface150). The mold also includes complementary thread-forming members 210Aand 210B. Thread-forming members 210A and 210B are constructed such thatthey create an aperture 220 through the diameter of plunger rod 130 atthe distal end portion thereof (see FIG. 3A). Because thread-formingmembers 210A and 210B do not occupy the entire cross-sectional area ofplunger rod 130, distal end portion 132 of plunger rod 130 is providedwith side walls 225 that define aperture 220 through the distal endportion 132 of plunger rod 130 (see FIG. 3B). Because thread-formingmembers 210A and 210B have threads formed thereon, side walls 225defining aperture 220 through plunger rod 130 have threads 226 moldedtherein. Core pin 230 also is included in the injection molding processin order to define an axial channel 235 through distal end portion 132of plunger rod 130, axial channel 235 extending from the extreme distalend of plunger rod 130 to aperture 220. In use, a male threaded member,e.g., connection member 160 formed on piston/plunger 52, can be insertedinto axial channel 235 defined in plunger rod 130 until the threads onthe male threaded member come into contact with threads 226 defined onside walls 225 adjacent to aperture 220. The male threaded member canthen be threadably secured to threads 226. As above-discussed, the useof complementary threaded members is merely illustrative of connectionmembers 160, 190 that can be used in connection with the presentinvention. Other known approaches for providing the desired mechanicalconnection between plunger rod 130 and piston/plunger 52 will beunderstood and appreciated by those of ordinary skill in the relevantart.

One of the significant benefits from using mold 200 havingthread-forming members 210A and 210 and core pin 230 arises in thatplunger rod 130 does not need to be rotationally released from the moldsafter it has been formed. Instead, mold 200 is simply moved radiallyoutwardly relative to the injection molded plunger rod 130 and core pin230 is moved axially and distally relative to the injection moldedplunger rod 130 in order to release plunger rod 130 from mold 200 andcore pin 230. The elimination of the need to rotationally remove plungerrod 130 from mold 200 and/or core pin 230 is significant in high speed,high quantity manufacturing.

FIGS. 6A and 6B illustrate an alternative structure on the distal end ofthe rod 130 for attaching plunger rod 130 to piston/plunger 52. As shownin FIG. 6A, distal end portion 132 of plunger rod 130 includes aconnection member 190 in the form of a pair of resilient flaps 191.Flaps 191 are constructed to engage a complementary barbed post 192projecting from piston/plunger 52, as is illustrated in FIG. 6B. Thoseskilled in the art will appreciate that the configuration shown in FIG.6 is offered by way of example and not limitation and that any number ofother alternatives for attaching plunger rod 130 to piston/plunger 52are possible.

Another embodiment of the injector device 100′ is shown in FIGS. 13-32.This embodiment of the injector device 100′ is adapted to receive andhold a pharmaceutical cartridge or ampule 155′ containing apharmaceutical product. The injector device 100′ generally comprises asyringe or injector body 105′, a plunger rod 130′, a cartridge 155′, ahub 20′, a hub clip 21′, a first hub cap 180′ and a second cap 181′.

As shown in FIG. 13, the plunger rod 130′ is mounted on injector body105′ in a first position. In this embodiment the injector body 105′ hasa sidewall 110′ with an outer surface 115′ and an inner surface 120′. Ina preferred embodiment, the injector body 105′ is preferably tubular ingeometry. However, while the sidewall 110′ is illustrated in theaccompanying figures as being tubular or cylindrical in shape, it willbe appreciated that the shape of side wall 110′ can be varied fordifferent purposes and to accept various shaped cartridges 155′. Theinner surface 120′ of side wall 110′ defines a cavity or region 125′ forreceiving at least a portion of cartridge 155′ therein.

The injector body 105′ has a proximal end portion 106′ and a distal endportion 107′. The injector body 105′ further has a first opening 127′ tothe cavity 125′ at the distal end portion 107′ of the body 105′, and asecond opening 129′ to the cavity 125′ at the proximal end portion 106′thereof. As is shown in FIGS. 14-17, the injector body 105′ also has apair of grip openings 31′ extending through the sidewall 110′ and intothe cavity 125′. As is explained in detail herein, the grip openings 31′assist the user in activating the cartridge 155′ and dispensing thepharmaceutical product from the cartridge 155′. The grip openings 31′also allow the finger grips 145′ to have a decreased size.

In this embodiment the pharmaceutical cartridge 155′ is typicallyinserted into the cavity 125′ of the body 105′ through the first opening127′ at the distal end 107′ of the body 105′. In the inactivatedposition, as shown in FIG. 16, the cartridge 155′ is fitted into thecavity 125′ through the first opening 127′, and pushed axially backtoward the second opening 129′. As explained herein, the proximal endportion 156′ of the cartridge 155′ is generally positioned adjacent thepushing surface 152′ of the plunger rod 130′ in the inactivatedposition. Alternately, the pharmaceutical cartridge 155′ can be insertedthrough an aperture in the sidewall 110′ as described in the priorembodiment, or through the second opening 129′ in the body 105′.

In a preferred embodiment the injector body 105′ is preferably made of aplastic material, and preferably a generally rigid plastic material,such as acrylic or polystyrene. Additionally, the injector body 105′ ispreferably clear or transparent, allowing the cartridge 155′ insertedinto the cavity 125′ of the injector body 105′ to be visible through thesidewall 110′ of the injector body 105′. In this manner, a bar code (notshown) on the outer wall of the cartridge 155′ can be visible throughthe sidewall 110′ of the injector body 105′ and can be scanned throughthe sidewall 110′ when the pharmaceutical cartridge 155′ is seated inthe injector body 105′. Alternately, the injector body 105′ can beconstructed of a flexible, resilient material such as more flexibleplastic, or even a metal. In yet another alternative embodiment,injector body 105′ can be formed by two or more pieces connected by ahinge member.

As shown in FIGS. 23 and 24, the injector body 105′ has one or moreretention members 135′ positioned on the outer surface 115′ of theinjector body 105′. In this embodiment the retention members 135′ areutilized to fixedly retain the plunger rod 130′ to the injector body105′ until usage of the syringe 100′ of the cartridge 155′. As explainedherein, in a preferred embodiment the plunger rod 130′ cannot be removedfrom the injector body 105′ unless the retention members 135′ are brokenfrom the injector body 105′, thus providing tamper proof evidence of thesecurity of the cartridge 155′ for the syringe system 100′.

In a preferred embodiment, the retention members 135′ comprise retentionposts 136′ projecting radially outwardly from the outer surface 115′ ofthe injector body 105′. Further, in a preferred embodiment, two or moreposts 136′ are utilized, thereby fixedly retaining the plunger rod 130′in position until activation. Each of the posts 136′ preferably have atleast one tab 33′ extending transversely therefrom, and preferablyradially outwardly therefrom. As is explained herein, the tabs 33′ areutilized to fixedly connect the retention members 135′ to the retainingmembers 35′ of the plunger rod 130′ to secure the plunger rod 130′ tothe outer surface 115′ of the injector body 105′. The post 136′ also hasa necked down portion 37′ adjacent the outer surface 115′ of thesidewall 110′ of the injector body 105′. The necked down portion 37′ hasa smaller cross-sectional area that allows any force, and particularlytransverse or axial forces by the plunger rod 130′, to be concentratedat the necked down portion 37′ such that the force necessary to shearthe posts 136′ for activation of the system 100′ will be reduced.

Although the second embodiment of the injector system 100′ is depictedin the accompanying figures as include two retention members 135′, e.g.,two retention posts 136′ having tabs 33′, it will be appreciated that afewer number or greater number of retention members 135′ can be used tosecure the plunger rod 130′ to outer surface 115′ of side wall 110′ ofinjector body 105′. Similarly, the details of the construction ofretention members 135′ and receiving or retaining members 35′ set forthherein are not intended to be limited to the post and apertureconfiguration depicted in the accompanying drawings for the secondembodiment of the injector system. One of ordinary skill in the art willrecognize that various modifications can be made to the number andconfiguration of retention members 135′ and receiving or retainingmembers 35′ without departing from the spirit and scope of the presentinvention. In short, the accompanying figures are intended to beillustrative, not limiting, with respect to the configuration and numberof retention member 135′ and receiving or retaining members 35′.

The injector body 105′ preferably includes finger grips 145′. Fingergrips 145′ are configured such that a medical professional usinginjector device 100′ of the present invention will engage them withhis/her index and middle fingers during normal use to push on the pushermember 150′ of the plunger rod 130′. In one embodiment shown in FIGS.23-24, the finger grips 145′ are generally planer members extending fromthe outer surface 115′ of the sidewall 110′ of the injector body 105′.In this embodiment the finger grips 145′ are positioned adjacent therespective grip openings 31′ in the sidewall 110′ of the injector body105′. Further, in one embodiment the finger grips 145′ are positionedapproximately 90° apart from the retention posts 136′. Accordingly, whenthe user grips the injector body 105′ with her fingers to push on thepusher member 150′ of the plunger rod 130′, the user's fingers do notengage the sidewall 110′ of the injector body 105′, but rather extendpast the sidewall 110′ of the injector body 105′ and through the gripopenings 31′ and partially into the cavity 125′ of the injector body105′. Preferably, the cartridge 155′ in the cavity 125′ of the injectorbody 150′ operates as a stop for the user's fingers. Thus, whereas inthe prior embodiment the maximum distance between the end of the fingergrips 145 to the radial finger stop is defined by the distance from theend of the finger grips 145 to the outer surface 115′ of the sidewall110′ of the injector body 105′, in this embodiment the maximum distanceis defined by the distance from the end of the finger grips 145′ to theouter surface of the cartridge 155′. Since the outer surface of thecartridge 155′ is approximately 0.10″ radially inward of the outersurface 115′ of the sidewall 110′ of the injector body 105′, to have thesame finger grip surface area as the prior embodiment each finger grip145′ can be approximately 0.10″ shorter than the prior embodiment. Thisleads to nearly ¼″ of savings in the overall width of the overallinjector body 105′ having finger grips 145′.

Alternatively, the finger grips may be convex on a distal side of fingergrips and concave on a proximal side of finger grips to more closelymatch the geometry of a user's fingers. It will be appreciated that thesize and shape of finger grips can be modified without departing fromthe scope of the present invention.

The injector body 105′ also has a receiver 39′ for receiving the hubclip 21′. The receiver 39′ comprises a plurality of openings 41′ throughthe sidewall 110′ of the injector body 105′. In a preferred embodimentthe receiver 39′ is located toward the distal end portion 107′ of theinjector body 105′. The hub clip 21′ is described in greater detailherein.

Referring now to FIGS. 25-30, the plunger rod 130′ is shown. The plungerrod 130′ has a body portion 51′ with a proximal end portion 131′ and adistal end portion 132′. The retaining members 35′ are provided as partof the plunger rod 130′. The retaining members 35′ are also referred toas receiving members 35′. In one embodiment, the retaining members 35′comprise retaining apertures 35′. In a preferred embodiment, a pluralityof retaining apertures 35′ are provided in the body portion 51′ of theplunger rod 130′, preferably between the proximal end portion 131′ andthe distal end portion 132′ thereof. The retaining apertures 35′ areconstructed to cooperate with retention members 135′, particularly theretention posts 136′ having transverse tabs 33′, to fixedly retain theplunger rod 130′ to the injector body 105′ until activation of thepharmaceutical cartridge 155′. In a preferred embodiment, the injectorbody 105′ has two retention posts 136′, and the plunger rod 130′ has twocorresponding retaining or receiving apertures 35′. Additionally, in apreferred embodiment the main body portion 51′ of the plunger rod 130′has a generally C-shaped cross-section, with the outer convex surface ofthe body 51′ facing radially outward from the sidewall 110′ of theinjector body 105′. This configuration makes it more difficult for anindividual to grasp the plunger rod 130′ to remove it from the injectorbody 105′ utilizing a radial outward force.

The retaining apertures 35′ have a plurality resilient fingers 43′positioned therein. As shown in FIG. 29, in a preferred embodiment thereare four resilient fingers 43′ in each retaining aperture 35′, however,it is readily understood by one of ordinary skill in the art that afewer or greater number of resilient fingers 43′ would suffice. Further,as shown in FIGS. 26 and 27, the resilient fingers 43′ are connected tothe body of the plunger rod 130′ adjacent the top surface 45′ of theplunger rod 130′, and extend toward the lower surface 47′ of the plungerrod 130′. It is understood that the lower surface 47′ of the plunger rod130′ contacts or is adjacent the outer surface 115′ of the injector body105′ when the plunger rod 130′ is secured to the injector body 105′. Thetop surface 45′ of the plunger rod 130′, however, faces away from theinjector body 105′ when the plunger rod 130′ is connected to theinjector body 105′ as shown in FIG. 13. Each of the resilient fingers43′ are hinged or cantilevered from their connection with the plungerrod 130′ adjacent the top surface 45′ of the plunger rod 130′, and thedistal end 49′ of the resilient fingers 43′ extend into a cavity of theinjector rod 130′ beneath the top surface 45′ of the plunger rod 130′.The distal end 49′ of each resilient finger 43′ also has a flange 53′extending radially inwardly into the cavity of the retaining aperture35′. The flanges 53′ of each resilient finger 43′ are utilized to engagethe tabs 33′ extending from the retention posts 136′.

To connect or attach the plunger rod 130′ to the injector body 105′, thelower surface 47′ of the plunger rod 130′ is positioned over the outersurface 115′ of the injector body 105′, with the retention posts 136′extending from the injector body 105′ aligned with the retainingapertures 35′. The plunger rod 130′ is then forced toward the injectorbody 105′ such that the retention posts 136′ engage the retainingapertures 35′. As the retention posts 136′ are inserted into theretaining apertures 35′ the retention posts 136′ cause the distal end49′ portion of the resilient fingers 43′ to flex radially outwardly.Additionally, as the retention posts 136′ are inserted further into theretaining apertures 35′, the transverse tabs 33′ on the retention posts136′ extend past the flanges 53′ on the resilient fingers 43′ and arecaptured by the flanges 53′. Once the transverse tabs 33′ on theretention posts 136′ are captured by the flanges 53′ the plunger rod130′ is locked in place on the injector body 105′ and the plunger rod130′ cannot be removed from the injector body 105′ without fracturingthe retention posts 136′. Specifically, the tabs 33′ prevent radialmovement of the plunger rod 130′ off the injector body 105′, and theposts 136′ prevent axial movement of the plunger rod 130′ with respectto the injector body 105′. Accordingly, since the plunger rod 130′ isfixedly retained to the injector body 105′ by the cooperation betweenthe retention members 135′ and the receiving apertures 35′, and sincethe posts 136′ are broken from the exterior wall of the injector body105′ upon activation of the system 100′, the plunger rod 130′ cannot bere-attached to the injector body 105′ after the posts 136′ are broken,thereby providing a visual safety or tamper-evident indicator asdescribed herein. Further, since the plunger rod 130′ is fixedlyattached to the injector body 105′ prior to activation, the packagingnecessary to maintain the system 100′ together may be reduced. Forexample, instead of having to package or overwrap each injector body105′ and associated plunger rod 130′ together with separate packaging, aplurality of injector systems 100′ (with the associated plunger rod 130′fixedly attached to the injector body 105′) may be mass grouped orpackaged in larger quantities in a single container.

As shown in FIGS. 16, 18, 25 and 30, the proximal end portion 131′ ofthe plunger rod 130′ has a pushing member 150′. In one embodiment thepushing member 150′ comprises a flange extending from the main body ofthe plunger rod 130′. The pushing member 150′ includes a proximalsurface 151′ that is constructed for engagement with a medicalprofessional's thumb. In use, a medical professional will grasp injectorbody 105′ such that his/her index and middle fingers are in contact witha distal surface of finger grips 145′ and such that his/her thumb is incontact with proximal surface 151′ of pushing member 150′. The pushingmember 150′ is utilized to assist the user in both activating thepharmaceutical cartridge 155′ as well as dispensing the contents of thepharmaceutical cartridge 155′.

The pushing member 150′ also includes a cartridge pushing surface 152′.The pushing surface 152′ is utilized to transition the cartridge 155′from the inactivated position, as shown in FIGS. 15 and 16, to theactivated position, as shown in FIG. 31. More specifically, the pushingsurface 152′ is constructed to engage the proximal end portion 156 ofpharmaceutical cartridge 155′ and to urge proximal end portion 156′ ofpharmaceutical cartridge 155′ distally into the activated position as amedical professional squeezes his/her index and middle fingers towardshis/her thumb. The importance of surface for pushing 152′ will bedescribed in greater detail later in this specification. In oneembodiment the cartridge pushing surface 152′ includes a nub 153′extending axially away from the pushing member 150′. In one embodiment,as best shown in FIG. 16, the nub 153′ is configured to engage thepharmaceutical cartridge 155′ for activating the pharmaceuticalcartridge 155′. Further, in a preferred embodiment, the nub 153′ isconfigured to be positioned partially within a cavity 154′ at theproximal end portion 156′ of the cartridge 155′. In this manner, the nub153′ operates to substantially block or preclude access to the contentsof the pharmaceutical cartridge 155′ through the proximal end portion156′, i.e., through the grommet of the pharmaceutical cartridge 155′.Accordingly, in such a preferred embodiment the nub 153′ has a geometrythat mates with the geometry of the cavity of the cartridge 155′. Sincethe plunger rod 130′ is connected to the injector body 105′, and thusthe nub 153′ is fixed in place in this position, the nub 153′ will bepositioned within the cavity 154′ at the proximal end portion 156 of thecartridge 155′ upon the cartridge 155′ being inserted into the cavity125′ of the body 105′ through the first opening 127′ at the distal end107′ of the body 105′ and pushed axially back toward the second opening129′. In an alternative embodiment, nub 153′ is substantiallycylindrical or conical in shape and has a size that allows it to bepositioned within, and to move within, the proximal end portion 156′ ofpharmaceutical cartridge 155′. In this alternative embodiment, nub 153′prevents access to the contents of the pharmaceutical cartridge 155′through the proximal end portion 156′ thereof.

In one embodiment, as shown in FIGS. 25-29, the plunger rod 130′ alsohas a connection member 190′ at the distal end portion 132′ of theplunger rod 130′. The connection member 190′ is utilized to connect theplunger rod 130′ to the piston/plunger 52′ in the pharmaceuticalcartridge 155′. In a preferred embodiment, the piston/plunger 52′ in thepharmaceutical cartridge 155′ has a connection member 160′ extending outthe proximal end portion 156′ of the cartridge 155′. The connectionmember 190′ of the injector rod 130′ is adapted to connect to theconnection member 160′ of the pharmaceutical cartridge 155′. In apreferred embodiment, the connection member 160′ of the pharmaceuticalcartridge 155′ is a threaded member. In such an embodiment where theconnection member 160′ is a threaded member, a complementary connectionmember 190′ having complementary threads is provided on distal endportion 132′ of plunger rod 130′ such that plunger rod 130′ can bethreadably attached to connection member 160′ on piston/plunger 52′,thereby enabling a user to move piston/plunger 52′ proximally and/ordistally through the application of proximally and/or distally directedforces to plunger push surface 150′ and/or to plunger rod 130′. Asdiscussed herein, connection members 160′ and 190′ can have a variety ofconfigurations so long as they provide the desired attachment of plungerrod 130′ to piston/plunger 52′. For example, connection members 160′ and190′ can be constructed to provide a pressure, friction or snap fittherebetween. Other configurations of connection members 160′ and 190′will be readily appreciated by persons of ordinary skill in the art.

In the various embodiments illustrated herein, the injector body 105′and plunger rod 130′ are depicted as separate pieces. These pieces canbe injection molded or formed using a variety of other known toolingtechniques. It will also be appreciated that injector body 105′ andplunger rod 130′ can be unitarily injection molded without departingfrom the intended spirit and scope of the present invention.Additionally, the injector body 105′ and plunger rod 130′ can beprovided separately from the pharmaceutical cartridge 155′ such that amedical professional, i.e., a pharmacist, inserts pharmaceuticalcartridge 155′ into the injector body 105′ immediately prior to use.Alternatively, the injector body 105′ and the pharmaceutical cartridge155′ can be pre-assembled by a manufacturer or assembler and supplied incombination to medical professionals. In a preferred embodiment, thepharmaceutical cartridge 155′ is inserted into the injector body 105′and the injector system 100′ is fully assembled prior to providing tothe medical professional.

Injector body 105′ and plunger rod 130′ can be constructed from avariety of known materials, including metals, plastics, and variousknown composites. In order to minimize cost, plastic may be preferable.A variety of known plastic materials providing the requisite rigidityand other performance characteristics can be used in conjunction withthe present invention.

The pharmaceutical cartridge 155′ used in conjunction with the presentinvention can have a variety of configurations. Generally, thepharmaceutical cartridge 155′ is a thin-walled tubular memberconstructed to retain a pharmaceutical product within an interior spaceor cavity 40′ of the cartridge 155′. The pharmaceutical cartridge 155′has a cartridge body having a proximal end portion 156′ and a distal endportion 157′. The pharmaceutical cartridge 155′ also has an interiorspace or cavity 40′ wherein the medicament is housed. As shown in FIG.16, a piston/plunger 52′ is slidably positioned within the interiorspace 40′ at the proximal end portion 156′ of pharmaceutical cartridge155′, and fluidly seals the proximal end portion 156′ of pharmaceuticalcartridge 155′, and a pierceable diaphragm 50′ fluidly seals the distalend portion 157′ of the cavity 40′ of the cartridge 155′. In a preferredembodiment a connection member 160′, e.g., threaded rod, is attached topiston/plunger 52′ such that the connection member 160′ is accessiblefrom the exterior of cartridge 155′.

In most cases it will be preferable to construct pharmaceuticalcartridge 155′ from known glass materials due to the relative inactivitybetween glass and most pharmaceutical products. However, it will beappreciated that in certain cases it may be appropriate or necessary touse non-glass materials due to the possible interaction between thepharmaceutical product to be contained in pharmaceutical cartridge 155′and the material from which pharmaceutical cartridge 155′ isconstructed.

As shown in FIGS. 14, 16 and 22, a hub 20′ is slidably mounted on thedistal end portion 157′ of the pharmaceutical cartridge 155′. In oneembodiment the hub 20′ comprises a mounting portion 23′ at a proximalend 25′, a connecting portion 170′ at a distal end 27′, and a neckeddown portion 175′ between the mounting portion 23′ and the connectingportion 170′. Further, the hub 20′ has a bore 29′ extending from thedistal end 27′ to the proximal end 25′ thereof. A piercing member (orneedle cannula) 18′ is fixed in place in the bore 29′ of the hub 20′.The piercing member 18′ is constructed to pierce the pierceablediaphragm 50′. The mounting portion 23′ of the hub 20′ has a sidewall61′ and a bottom wall 63′. The sidewall 61′ of the hub 20′ is slidinglysecured to the sidewall of the cartridge 155′ at the distal end portion157′ of the cartridge 155′ in the inactivated position as shown in FIG.16. In that inactivated position, a gap 64′ is provided between thedistal end 157′ of the cartridge 155′ and the bottom wall 63′ of themounting portion 23′ of the hub 20′.

As explained herein, the hub 20′ is fixed in place (longitudinally androtationally) in the injector body 105′ via the hub clip 21′, however,the pharmaceutical cartridge 155′ is slidable with respect to the hub20′ between a first, inactivated position in which piercing member 18′is positioned outside of cartridge 155′ and distally of pierceablediaphragm 50′ (as shown in FIG. 16), and a second, activated position inwhich piercing member 18′ is disposed through pierceable diaphragm 50′and in which interior lumen 165′ defined by piercing member 18′ is influid communication with the contents in the cavity 40′ of cartridge155′, thereby providing a pathway for the egress of fluids fromcartridge 155′ through piercing member 18′ in response to pressureapplied when piston/plunger 52′ is moved distally by the plunger rod130′. In the inactivated position the gap 64′ is provided between thedistal end 157′ of the cartridge 155′ and the bottom wall 63′ of themounting portion 23′ of the hub 20′. During activation, however, the hub20′ remains fixed in place and the cartridge 155′ is moved axiallydistally toward the bottom wall 63′ of the mounting portion 23′ of thehub 20′. In one embodiment, the bottom wall 63′ of the mounting portion23′ of the hub 20′ operates as a stop for the cartridge 155′.

Referring to FIGS. 14, 16 and 22, the hub clip 21′ is used to fix thehub 20′ in place in the injector body 105′. As explained above, theinjector body 105′ has a receiver 39′ for receiving the hub clip 21′. Inthis embodiment the receiver 39′ comprises a plurality of openings 41′through the sidewall 110′ of the injector body 105′. The receiver 39′ isshown in FIGS. 23 a and 24. When the pharmaceutical cartridge 155′ andhub 20′ are inserted into the cavity 125′ of the injector body 105′through the first opening 127′ at the distal end 107′ of the injectorbody 105′, the cartridge 155′ is pushed axially back toward the secondopening 129′ until the proximal end portion 156′ of the cartridge 155′contacts the pushing surface 152′ of the pusher member 150′ of theplunger rod 130′. In this position the necked down portion 175′ of thehub 20′ will be aligned with the openings 41′ in the sidewall 110′ ofthe injector body 105′.

In one embodiment the hub clip 21′ has a plurality of projections 65′that extend through the openings 41′ in the sidewall 110′ of theinjector body 105′. The hub clip 21′ also has an outer geometric shapesimilar to the shape of the exterior surface of the sidewall 110′ of theinjector body 105′. In a preferred embodiment the width of theprojections 65′ are generally similar to the width of the necked-downportion 175′ of the hub 20′. Thus, when the hub 20′ is positioned in theinjector body 105′, and after the clip 21′ is inserted through theopenings 41′ in the sidewall 110 of the injector body 105′, theprojections 65′ preclude any axial movement of the hub 20′.Additionally, the shape of the projections 65′ engages fins extendingfrom the body of the hub 20′ in the necked-down region 175′ such thatthe hub 20′ is also precluded from rotating in the injector body 105′.Finally, the hub clip 21′ has resilient tabs 67′ that snap into place atvarious openings 41′ in the injector body 105′ sidewall 110′ to keep theclip 21′ fixed in place on the injector body 105′. Further, in order toprevent the clip 21′ from being removed from the injector body 105′, alabel is typically placed around the body 105′ and the clip 21′. Thelabel (not shown) may also secure the cap 181′ to the injector body105′. To remove the cap 181′ from the body 105′, it will be necessary totear the label, thereby providing visual evidence (i.e., tamperevidence) of such occurrence.

Similar to connecting portion 170′ described in the prior embodiment,the connection portion 170′ of the hub 20′ in this embodiment isconfigured to deliver the pharmaceutical product contained inpharmaceutical cartridge 155′ to a patient or to another medicalapparatus, e.g., a tube set configured to deliver pharmaceuticalproducts to a patient. The connection portion 170′ may be a threadedluer member constructed to connect with a complementary luer member. Itwill be appreciated that connection portion can have a variety ofconfigurations, including: (i) a hypodermic needle for delivery ofpharmaceutical products directly to a patient or for delivery through apierceable septum, e.g., a pierceable septum associated with an add portof a tube set or an add port of a flexible pharmaceutical container;(ii) a blunt needle for delivery of pharmaceutical products frompharmaceutical cartridge to a medical device having the capability ofreceiving a pharmaceutical product from a blunt needle, e.g., a pre-slitelastomeric seal on a tube set or a flexible pharmaceutical container;(iii) threaded luer; and/or (iv) an unthreaded luer.

A first hub cap 180′ is provided to mate with the connection portion170′ and cover the exposed end of the needle cannula 18′. A short secondhub cap 181′ is joined to the first hub cap 180′, generally via a pressfit, and provides a member for the medical professional to grasp forremoving the first and second hub caps 180′, 181′ from the hub 20′ toexpose the needle cannula 18′. Cap members 180′ and 181′ can be providedin order to cover the connector 170′ and cannula 18′ when the injectordevice 100′ of the present invention is not in use. The cap members 180′and 181′ are preferably constructed of a material that will precludeaccess to the contents of the cartridge 155′ through the cap 181′. Theend of the cap 181′ is flat, thereby reducing the overall length of thesystem 100′.

The cartridge 155′ may be loaded into the cavity of the injector body105′ from either the proximal end 106′ or the distal end 107′ of thebody 105′, as long as the plunger rod 130′ is not connected to the body105′ first. If the plunger rod 130′ is connected to the body 105′, thenthe pushing member precludes access of the cartridge 155′ through thesecond opening 129′ at the proximal end 106′, and the cartridge 155′must be inserted through the first opening 127′ at the distal end 107′of the body 105′.

In order to use injector device 100′, a medical professional will engagefinger grips 145′ with his/her index and middle fingers and will engageproximal surface 151′ of plunger push surface 150′ with his/her thumb.By squeezing his/her thumb and fingers together, plunger push surface150′ and finger grips 145′ are moved closer to one another. Also bysqueezing his/her thumb and fingers together, the pushing surface 152′and associated nub 153′ apply an axial distal force on proximal endportion 156′ of pharmaceutical cartridge 155′. However, because the hubclip 21′ precludes axial distal movement of the hub 20′, the applicationof a distally directed axial force on proximal end portion 156′ ofpharmaceutical cartridge 155′ causes pharmaceutical cartridge 155′ tomove from its first, inactivated position (see FIG. 16) toward itssecond, activated position (see FIG. 31). The squeezing force alsocauses plunger rod 130′ to move axially distally relative to injectorbody 105′ from its first, engaged position (shown in FIG. 16) in whichthe retention members 135′ are connected to the injector body 105′ andretained in the receiving or retaining apertures 35′, to its second,released position in which the retention posts 136′ are sheared from theinjector body 105′ at the necked down portion 37′ of the posts 136′. Theposts 136′ are retained in the receiving apertures 35′. After the postsare sheared from the injector body 105′, the resilient fingers 43′retain the posts 136′ in the receiving apertures 35′. In operation,pharmaceutical cartridge 155′ is in its second, activated position whenplunger rod 130′ is in its second, released position. In the secondreleased position the plunger rod 130′ is free from the injector body105′ and can be removed therefrom.

After the posts are sheared from the injector body 105′, the plunger rod130′ can be removed from the injector body 105′ and positioned such thatthe distal end portion 132′ of the plunger rod 130′ is adjacent toconnection member 160′ on piston/plunger 52′. Where connection member160′ is a threaded member, a complementary connection member 190′ havingcomplementary threads is provided on the distal end portion 132′ ofplunger rod 130′ such that plunger rod 130′ can be threadably attachedto connection member 160′ on piston/plunger 52′ as shown in FIG. 32,thereby enabling a user to move piston/plunger 52′ proximally and/ordistally through the application of proximally and/or distally directedforces to plunger push surface 150′ and/or to plunger rod 130′. Asdiscussed above, connection members 160′ and 190′ can have a variety ofconfigurations so long as they provide the desired attachment of plungerrod 130′ to piston/plunger 52′. For example, connection members 160′ and190′ can be constructed to provide a friction or snap fit therebetween.Other configurations of connection members 160′ and 190′ will be readilyappreciated by persons of ordinary skill in the art of the presentinvention.

After plunger rod 130′ has been connected to piston/plunger 52′ usingcomplementary connection members 160′, 190′, a pharmaceutical productcontained in pharmaceutical cartridge 155′ can be delivered to a patientor transferred to another medical device by the application of an axialdistally-directed force to plunger rod 130′, e.g., through theapplication of a distally directed force to proximal surface 151′ ofplunger push surface 150′. If desired, fluids can be aspirated intopharmaceutical cartridge at any time through the application of aproximally directed force to plunger push surface 150′.

Another embodiment of the injector device 100″ is shown in FIGS. 33-58.This embodiment of the injector device 100″ is also adapted to receiveand hold a pharmaceutical cartridge or ampule 155″ containing apharmaceutical product, and for dispensing a drug therefrom. Thisembodiment of the injector device 100″ generally comprises a syringehousing or injector body 105″, a plunger rod 130″, a hub clip 21″, and atamper-evident band 194″. In one embodiment the cartridge systemgenerally comprises a cartridge 155″, a hub 20″, a first or inner hubcap 180″ and a second or outer cap 181″, however, it is understood thatalternate cartridge systems may be utilized with the injector device100″ without departing from the scope of the present invention.

In a preferred embodiment of this injector device 100″, the injectorbody 105″, plunger rod 130″, hub clip 21″ and tamper-evident band 194″are all manufactured in a multi-step, multi-shot molding process, suchthat assembly of the individual components to create the injector device100″ is not required. It is understood, however, that several featuresof this embodiment of the injector device 100″ retain aspects ofcomponents of the prior embodiment injector devices 100 and 100′, andthus like numbers are utilized herein. Additionally, since certainfeatures of this embodiment are similar to the prior-describedembodiments, those features may not be explained in further detailherein.

As shown in FIG. 33 of this embodiment, the plunger rod 130″ ismanufactured and mounted on the injector body 105″ in a first position.In this embodiment the injector body 105″ has a sidewall 110″ with anouter surface 115″ and an inner surface 120″. In a preferred embodiment,the injector body 105″ is preferably tubular in geometry. While thesidewall 110′ is illustrated in the accompanying figures as beingtubular or cylindrical in shape, it will be appreciated that the shapeof side wall 110″ can be varied for different purposes and to acceptvarious shaped cartridges 155″. The inner surface 120″ of side wall 110″defines a cavity or region 125″ for receiving at least a portion ofcartridge 155″ therein.

The injector body 105″ has a proximal end portion 106″ and a distal endportion 107″. The injector body 105″ further has a first opening 127″ tothe cavity 125″ at the distal end portion 107″ of the body 105″, and asecond opening 129″ to the cavity 125″ at the proximal end portion 106″thereof. As is shown in FIGS. 38 and 41-43, the injector body 105″ alsohas a pair of grip openings 31″ extending through the sidewall 110″ andinto the cavity 125″. As is explained in detail herein in priorembodiments, the grip openings 31″ assist the user in activating thecartridge 155″ and dispensing the pharmaceutical product from thecartridge 155″. The grip openings 31″ also allow the finger grips 145″to have a decreased size.

Since a preferred variation of the embodiment of this injector device100″ is manufactured together in a multi-step multiple-shot moldingprocess, the injector body 105″, plunger rod 130″, hub clip 21″ andtamper-evident band 194″ come pre-assembled. Thus, the pharmaceuticalcartridge 155″ is typically inserted into the cavity 125″ of the body105″ through the first opening 127″ at the distal end 107″ of the body105″. In the inactivated position, as shown in FIG. 37, the cartridge155″ is fitted into the cavity 125″ through the first opening 127″, andpushed axially back toward the second opening 129″. As explained herein,the proximal end portion 156″ of the cartridge 155″ is generallypositioned adjacent the pushing surface 152″ of the plunger rod 130″ inthe inactivated position.

In a preferred embodiment the injector body 105″ is preferably made of aplastic material, and preferably a generally rigid plastic material,such as polycarbonate. Additionally, the injector body 105″ ispreferably clear or transparent, allowing the cartridge 155″ insertedinto the cavity 125″ of the injector body 105″ to be visible through thesidewall 110″ of the injector body 105″. As explained herein, in thismanner a bar code (not shown) on the outer wall of the cartridge 155″can be visible through the sidewall 110″ of the injector body 105″ andcan be scanned through the sidewall 110″ when the pharmaceuticalcartridge 155″ is seated in the cavity 125″ of the injector body 105″.

As shown in FIGS. 34 and 47-50, the injector body 105″ has one or moreretention members 135″ positioned on the outer surface 115″ of theinjector body 105″. In this embodiment the retention members 135″ areutilized to preclude axial and rotational movement of the plunger rod130″ with respect to the injector body 105″ until activation of theinjector device 100″ is desired.

In a preferred embodiment, the retention members 135″ comprise aprotrusion 196″, such as a tenon 196″, projecting radially outwardlyfrom the outer surface 115″ of the injector body 105″. In the embodimentshown, a single retention member 135″ is utilized, however, it isunderstood that two or more retention members 135″ may be utilized tofixedly retain the plunger rod 130″ in position until activation. In apreferred embodiment, the retention members 135″ have a dovetail-typeconfiguration. Accordingly, as shown in FIGS. 46 and 50, the portion ofthe retention member 135″ proximal the outer surface 115″ of theinjector body 105″ has a narrower cross-sectional width, shown as beingperpendicular to the longitudinal axis of the injector body 105″, thanthe cross-sectional width of the portion of the retention member 135,″distal the outer surface 115,″ of the injector body 105″. Thisstructural configuration provides the retention members 135″ of thisembodiment with the identified dovetail-type configuration. Such ageometry, when used in conjunction with a mating configuration on theplunger rod 130″, positively precludes axial or upward (i.e., radiallyoutward) movement of the plunger rod 130″ off of the injector body 105″.From the top view, as shown in FIG. 48, in one embodiment the retentionmember 135″ has a figure eight-type shape. This assists in maintainingappropriate tolerances in retention member 135″ during the manufacturingof the retention member 135″, as well as assisting to maintain theappropriate removal forces for the plunger rod 130″. For manufacturingpurposes, a recess 198″ is provided in the top surface of the injectorbody 105″ adjacent the remember 135″ to allow for the insertion of moldcomponents in the manufacturing process.

Although this embodiment of the injector system 100″ is depicted in theaccompanying figures as including a single retention member 135″, itwill be appreciated that a greater number of retention members 135″ canbe used to secure the plunger rod 130″ to outer surface 115″ of sidewall 110″ of injector body 105″. Similarly, the details of theconstruction of retention members 135″ and receiving or retainingmembers 35″ set forth herein are not intended to be limited to theidentified configurations depicted in the accompanying drawings of theinjector system. For example, the retention member 135″ may extend agreater distance about the length of the joining surface of the plungerrod 130″ and the injector body 105″. One of ordinary skill in the artwill recognize that various modifications can be made to the number andconfiguration of retention members 135″ and receiving or retainingmembers 35″ (described in detail later herein) without departing fromthe spirit and scope of the present invention. In short, theaccompanying figures are intended to be illustrative, not limiting, withrespect to the configuration and number of retention members 135″ andreceiving or retaining members 35″.

The injector body 105″ also preferably includes finger grips 145″ whichare similar to the finger grips 145′ described in the precedingembodiment. Accordingly, the disclosure of such finger grips 145″ isdiscussed above.

In a preferred embodiment of this injector system 100″, the injectorbody 105″ has a receiver 39″ for receiving the hub clip 21″. In thisembodiment, however, rather than being a detached component that engagesthe receiver 399″, the hub clip 21″ is rotatedly connected or hinged(e.g., through a living hinge) directly to the injector body 105″, andcan rotate from a first position wherein the hub clip 21″ is not withinthe receiver opening 39″, thereby allowing the pharmaceutical cartridge155″ to be moveable longitudinally and rotationally in the cavity 125″of the injector body 105″, to a second position wherein the hub clip 21″retains the hub 20″ of the pharmaceutical cartridge 155″ in a fixedposition relative to the injector body 105″. The receiver 39″ preferablycomprises one or more openings 41″ through the sidewall 110″ of theinjector body 105″. In a preferred embodiment the receiver 39″ islocated toward the distal end portion 107″ of the injector body 105″.The hub clip 21″ and its rotational connection to the injector body 105″is described in greater detail herein.

As shown in FIGS. 45 and 47-49, to rotatedly or hingedly attach the hubclip 21″ to the injector body 105″, a pair of rods or hinge members 200″are provided as part of the injector body 105″. The rods 200″ extendlongitudinally within an arcuate plane of the sidewall 110″, such thatthe pivot point of the hub clip 21″ is within the thickness of thesidewall 110″ of the injector body 105″. In a preferred embodiment, therods 200″ are manufactured in connection with the manufacture of theinjector body 105″. Further, in a preferred embodiment there are tworods 200″, with a finger portion 202″ of the sidewall 110″ extendingtherebetween to reduce flexing such as if a single extended shaft wasused.

Referring to FIGS. 35, 37, 38, 43 and 45, the hub clip 21″ is used tofix the hub 20″ associated with the pharmaceutical cartridge 155′ inplace in the injector body 105″. As explained herein with respect toprior embodiments, the hub 20″ associated with the pharmaceuticalcartridge 155″ is fixed in place in the injector body 105″ via the hubclip 21″, however, the pharmaceutical cartridge 155″ is slidable withrespect to the hub 20″ between a first, inactivated position in whichpiercing member 18″ is positioned outside of cartridge 155″ and distallyof pierceable diaphragm 50″ (as shown in FIG. 37), and a second,activated position in which piercing member 18″ is disposed throughpierceable diaphragm 50″ and in which interior lumen 165″ defined bypiercing member 18″ is in fluid communication with the contents in thecavity 40″ of cartridge 155″, thereby providing a pathway for the egressof fluids from cartridge 155″ through piercing member 18″ in response topressure applied when piston/plunger 52″ is moved distally by theplunger rod 130″. During activation the hub 20″ remains fixed in placeby the hub clip 21″, and the cartridge 155″ is moved axially distallytoward the bottom wall 63″ of the mounting portion 23″ of the hub 20″.In a preferred embodiment the hub clip 21″ is preferably made of aplastic material, and preferably a generally rigid plastic material,such as High impact polystyrene.

As explained above, the injector body 105″ has a receiver 39″ forreceiving the hub clip 21″ to secure the hub clip 21″ in place. In thisembodiment the receiver 39″ comprises an opening 41″ through thesidewall 110″ of the injector body 105″. The receiver 39″ is shown inFIGS. 47-49. When the pharmaceutical cartridge 155″ and hub 20″ areinserted into the cavity 125″ of the injector body 105″ through thefirst opening 127″ at the distal end 107″ of the injector body 105″, thecartridge 155″ is pushed axially back toward the second opening 129″until the proximal end portion 156″ of the cartridge 155″ contacts thepushing surface 152″ of the pusher member 150″ of the plunger rod 130″.In this position the necked down portion 175″ of the hub 20″ will bealigned with the opening 41″ in the sidewall 110″ of the injector body105″.

As best shown in FIG. 45, the hub clip 21″ is rotatedly or hingedlyconnected to the injector body 105″ at the hinge members 200″ thereof.In one embodiment the hub clip 21″ has a projections 65″ that extendthrough the openings 41″ in the sidewall 110″ of the injector body 105″to engage the hub 20″. The projections 65″ extend from adjacent an endof the hub clip 21″ opposite the end connected to the hinge members200″. The outer surface of the hub clip 21″ has a geometry similar tothe shape of the exterior surface of the sidewall 110″ of the injectorbody 105″. In a preferred embodiment the width of the projection 65″ isgenerally similar to the width of the necked-down portion 175″ of thehub 20″. Thus, when the clip 21″ is rotated to its second or connectedposition shown in FIGS. 33 and 35, from its first or unconnectedposition shown in FIG. 45, the projections 65″ preclude any axialmovement of the hub 20″. The hub clip 21″ has a resilient tab 67″ thatsnaps into place in one of the openings 41″ in the sidewall 110″ of theinjector body 105″ to keep the clip 21″ fixed in place on the injectorbody 105″. Resilient tab 67″ and openings 41″ preferably are constructedsuch that it is relatively difficult to move clip 21″ back to its firstor unconnected position after it has been moved to its second orconnected position, thereby minimizing the possibility of tampering withthe contents of pharmaceutical cartridge 155″. Further, in order toprevent the clip 21″ from being removed from the injector body 105″, alabel may be placed around the body 105″ and the clip 21″. The label(not shown) may also secure the cap 181″ to the injector body 105″. Insuch an embodiment, to remove the cap 181″ from the body 105″ it will benecessary to tear the label, thereby providing visual evidence of suchoccurrence.

As described in the embodiment above, a connection portion 170″ of thehub 20″ is configured to deliver the pharmaceutical product contained inpharmaceutical cartridge 155″ to a patient or to another medicalapparatus, e.g., a tube set configured to deliver pharmaceuticalproducts to a patient. The connection portion 170″ is described indetail above.

Also as described in the embodiment above, a first hub cap 180″ isprovided to mate with the connection portion 170″ and cover the exposedend of the needle cannula 18″. And, a short second hub cap 181″ isjoined to the first hub cap 180″, generally via a press fit, andprovides a member for the medical professional to grasp for removing thefirst and second hub caps 180″, 181″ from the hub 20″ to expose theneedle cannula 18″. Cap members 180″ and 181″ can be provided in orderto cover the connector 170″ and cannula 18″ when the injector device100″ of the present invention is not in use.

Referring now to FIGS. 51-56, one embodiment of the plunger rod 130″ isshown. The plunger rod 130″ has a body portion 51″ with a proximal endportion 131″ and a distal end portion 132″. The plunger rod 130″ alsohas one or more retaining or receiving members 35″. In one embodiment,the retaining members 35″ comprise a receiving cavity 35″ for matinglyreceiving the retention members 135″ extending from the injector body105″. The retaining members 35″ are constructed to cooperate withretention members 135″ to retain the plunger rod 130″ on the injectorbody 105″ until activation of the pharmaceutical cartridge 155″. Thus,in this preferred embodiment, the retaining members 35″ comprise amating cavity or dovetail-style mortise 35″ to mate with thedovetail-style configured tenons 135″ extending from the injector body105″. Accordingly, the cavity 35″ of the retaining members 35″ has areverse geometry to that described for the retention members 135″ ofthis embodiment. Specifically, in one embodiment the portion of thecavity 35″ proximal the entrance to the cavity 35″has a narrowercross-sectional width, shown as being perpendicular to the longitudinalaxis of the plunger rod 130″, than the cross-sectional width of theportion of the cavity 35″ distal the entrance to the cavity 35″. In thismating configuration, radial and rotational movement of the plunger rod130″ is precluded by the dovetail-style connection. Only axial orlateral movement of the plunger rod 130″ can occur without fracturingthe retention members 135″. As is explained in detail herein, if lateralmovement of the plunger rod 130″ occurs, or if sufficient radial outwardor rotational force is applied to the plunger rod 130″ to fracture theretention member 135″, the tamper-evidence band 194″ will provide visualevidence of such occurrence.

For manufacturing purposes, a recess 204″ is provided in the bottomsurface of the plunger rod 130″ adjacent the retaining cavity 35″ toallow for the insertion and removal of mold components in themanufacturing process. Additionally, in a preferred embodiment theplunger rod 130″ is preferably made of a plastic material, andpreferably a generally rigid plastic material, such as high impactpolystyrene.

In a preferred embodiment the main body portion 51″ of the plunger rod130″ has a generally C-shaped cross-section, with the outer convexsurface of the body 51″ facing radially outward from the sidewall 110″of the injector body 105″. This configuration makes it more difficultfor an individual to grasp the plunger rod 130″ to attempt to remove theplunger rod 130″ from the injector body 105″ utilizing a radial outwardforce.

Once the retention members 135″ are captured in the retaining cavities35″ the plunger rod 130″ is locked in place on the injector body 105″and the plunger rod 130″ cannot be removed from the injector body 105″without fracturing the tamper-evident band 194″ (as well as possiblefracturing the retention members 135″). As is explained in detailherein, since the plunger rod 130″ is retained to the injector body 105″by the cooperation between the retention members 135″ and the receivingcavities 35″, and since the tamper evident bands 194″ are broken uponactivation of the system 100″ or upon removal of the plunger rod 130″from the injector body 105″, a visual safety or tamper-evident indicatoris provided to any subsequent user that the system 100′ is compromised.Further, since the plunger rod 130″ is fixedly attached to the injectorbody 105″ during manufacturing, the packaging necessary to maintain thesystem 100″ as a unit may be reduced. For example, instead of having topackage or overwrap each injector body 105″ and associated plunger rod130″ together with separate packaging, a plurality of injector systems100″ (with the associated plunger rod 130″ fixedly attached to theinjector body 105″) may be mass grouped or packaged in larger quantitiesin a single container.

As shown in FIGS. 35 and 51-56, the proximal end portion 131″ of theplunger rod 130″ has a pushing member 150″. In one embodiment thepushing member 150″ comprises a flange extending from the main body ofthe plunger rod 130″. The pushing member 150″ includes a proximalsurface 151″ that is constructed for engagement with a medicalprofessional's thumb. In use, a medical professional will grasp injectorbody 105″ such that his/her index and middle fingers are in contact witha distal surface of finger grips 145″ and such that his/her thumb is incontact with proximal surface 151″ of pushing member 150″. The pushingmember 150″ is utilized to assist the user in both activating thepharmaceutical cartridge 155″ as well as dispensing the contents of thepharmaceutical cartridge 155″.

The pushing member 150″ also includes a cartridge pushing surface 152″,which is generally opposite the proximal surface 151″. The pushingsurface 152″ is utilized to contact the cartridge 155″ to transition thecartridge 155″ from the inactivated position, as shown in FIGS. 35 and37, to the activated position (similar to that shown for the priorembodiment in FIG. 31). More specifically, the pushing surface 152″ isconstructed to engage the proximal end portion 156″ of pharmaceuticalcartridge 155″ and to urge proximal end portion 156″ of pharmaceuticalcartridge 155″ distally into the activated position as a medicalprofessional squeezes his/her index and middle fingers towards his/herthumb.

In one embodiment the cartridge pushing surface 152″ has a flange 153″extending axially away from the perimeter of the pushing member 150″ tocreate a cavity 159″, as shown in FIG. 51. Referring to FIG. 37, in thisembodiment the pusher surface 152″ and flange 153″ of the plunger rod130″ are configured as a female receiver to allow the proximal endportion 156″ of the cartridge 155″ to be positioned within the cavity159″ of the pushing member 150″ in the inactivated or standard position.The end portion 156″ of the cartridge 155″ thus operates as the malemember and is positioned within the female cavity 159″ of the pushingmember 150″. Since the end portion 156″ of the cartridge 155″ ispositioned within the cavity 159″, the system 100″ precludes access tothe contents of the pharmaceutical cartridge 155″ through the proximalend portion 156″, i.e., through the grommet of the pharmaceuticalcartridge 155′,′ as a safety feature.

In one embodiment, as shown in FIGS. 51-56, the plunger rod 130″ alsohas a connection member 190″ at the distal end portion 132″ of theplunger rod 130″. The connection member 190″ is utilized to connect theplunger rod 130″ to the piston/plunger 52″ in the pharmaceuticalcartridge 155″ as described in the preceding embodiments.

Similarly, the pharmaceutical cartridge 155″ used in conjunction withthe present invention can have a variety of configurations, which aredescribed herein with respect to other embodiments. Likewise, the hub20″, which is slidably mounted on the distal end portion 157″ of thepharmaceutical cartridge 155″, is also described herein in priorembodiments.

Referring to FIG. 34, the injector system 100″ of this embodiment alsohas a tamper-evident band 194″. In a preferred embodiment, thetamper-evident band 194″ is made of a polyethylene material that flexesto a point, and then fractures. As shown in FIG. 34, in one embodimentthe tamper-evident band 194″ comprises a first annular portion 206″ thatengages the injector body 105″, and a second portion 208″ that engagesthe plunger rod 130″. The second portion 208″ of the tamper evident band194″ has a notch 210″ that operates as a frangible region to break upona minimal force being applied to the plunger rod 130″ to activate thesystem 100″, thereby breaking the second portion 208″ into two pieces.

In one embodiment the tamper-evident band 194″ will break at the notch210″ upon approximately 0.003″ of movement of the plunger rod 130″.Additionally, in a preferred embodiment the tamper-evident band 194″ ismade of a different color, such as red, to draw attention from the useras a reminder to for the user to review the band 194″ for any fractureprior to usage of the system 100″.

As is explained in detail herein, if lateral movement of the plunger rod130″ occurs, or if sufficient radial outward or rotational force isapplied to the plunger rod 130″ to fracture the retention member 135″,the tamper-evidence band 194″ will provide visual evidence of suchoccurrence. Put another way, since the plunger rod 130″ is retained tothe injector body 105″ by the cooperation between the retention members135″ and the receiving cavities 35″, and since the tamper evident bands194″ are broken upon activation of the system 100″ or upon removal ofthe plunger rod 130″ from the injector body 105″, a visual safety ortamper-evident indicator is provided to any subsequent user that thesystem 100′ has been compromised. In usage, upon lateral movement of theplunger rod 130″ the band 194″ will break at the notch 210″ and theplunger rod 130″ can be removed from the injector body 105″. Thetamper-evident band 194″ generally remains affixed to the injector body105″ following fracture and removal of the plunger rod 130″.

In a preferred embodiment the injector device 100″ is manufactured in amulti-step multiple-shot molding process which creates the injector body105″, plunger rod 130″, hub clip 21″, and tamper-evident band 194″. Inone such embodiment the first step comprises the manufacture of thesyringe body 105″. In this step the entire syringe body 105″, includingthe hinge rods 200″, the retaining member 135″ and all other componentsdescribed herein, is molded in a mold utilizing a polycarbonatematerial. After the syringe body 105″ has been molded the mold isopened, the fixture holding the syringe body 105″ is rotated a certainnumber of degrees, and the mold is closed with the syringe bodyremaining in the mold cavity. In this next step the plunger rod 130″ andthe hinge clip 21″ are molded in proper position on the syringe body105″. Specifically, the plunger rod 130″ is molded on the retainingmembers 135″ to create the receiving members 35″, and the hinge clip 21″is molded over the hinge rods 200′ to allow the hinge clip 21″ to berotatedly connected to the syringe body 105″. Preferably, the materialsutilized to create the plunger rod 130″ and the hinge clip 21″ should bematerials that will not mechanically or chemically bond with thematerial of the syringe body 105″. In one embodiment the plunger rod130″ and hinge clip 21″ are made of a high impact polystyrene so as toprevent any mechanical or chemical bonding with the polycarbonate of thesyringe body 105″. After the plunger rod 130″ and hinge clip 21″ havebeen molded in place on the syringe body 105″, the mold is again openedand the fixture rotated once again. The mold is then closed around thesyringe body 105″ having the plunger rod 130″ and hinge clip 21″ affixedthereto. In this next step the tamper-evident band 194″ is molded aroundthe syringe body 105″ and plunger rod 130″. Again, in a preferredembodiment the material utilized to create the band 194″ should be amaterial that will not mechanically or chemically bond with thematerials of the syringe body 105″ and the plunger rod 130″. In oneembodiment the band 194″ is made of a polyethylene having a colorant,such as red. After the band 194″ has been molded on the components ofthe injector system 100″ the mold is opened and the finished componentremoved.

In order to use injector device 100″, a medical professional will engagefinger grips 145″ with his/her index and middle fingers and will engageproximal surface 151″ of plunger push surface 150″ with his/her thumb.By squeezing his/her thumb and fingers together, plunger push surface150″ and finger grips 145″ are moved closer to one another. Also bysqueezing his/her thumb and fingers together, the pushing surface 152″applies an axial distal force on proximal end portion 156″ ofpharmaceutical cartridge 155″. However, because the hub clip 21″precludes axial distal movement of the hub 20″, the application of adistally directed axial force on proximal end portion 156″ ofpharmaceutical cartridge 155″ causes pharmaceutical cartridge 155″ tomove from its first, inactivated position (see FIG. 35) toward itssecond, activated position. The squeezing force also causes plunger rod130″ to move axially distally relative to injector body 105″ from itsfirst, engaged position, to its second, released position in which thereceiving members 35″ are disengaged from the retention members 135″.During this axial movement the tamper-evident band 194″ is fractured atthe notch 210″. Additionally, the pharmaceutical cartridge 155″ istransferred to its second, activated position when plunger rod 130″ ismanipulated to its second, released position. In the second releasedposition the plunger rod 130″ is now free from the injector body 105″and can be removed therefrom.

Next, the plunger rod 130″ can be positioned such that the distal endportion 132″ of the plunger rod 130″ is adjacent to connection member160″ on piston/plunger 52″. Where connection member 160″ is a threadedmember, a complementary connection member 190″ having complementarythreads is provided on the distal end portion 132″ of plunger rod 130″such that plunger rod 130″ can be threadably attached to connectionmember 160″ on piston/plunger 52″, thereby enabling a user to movepiston/plunger 52″ proximally and/or distally through the application ofproximally and/or distally directed forces to plunger push surface 150″and/or to plunger rod 130″.

After plunger rod 130″ has been connected to piston/plunger 52″ usingcomplementary connection members 160″, 190″, a pharmaceutical productcontained in pharmaceutical cartridge 155″ can be delivered to a patientor transferred to another medical device by the application of an axialdistally-directed force to plunger rod 130″, e.g., through theapplication of a distally directed force to proximal surface 151″ ofplunger push surface 150″. If desired, fluids can be aspirated intopharmaceutical cartridge at any time through the application of aproximally directed force to plunger push surface 150″.

While various aspects of the invention have been discussed herein inconnection with certain preferred embodiments, it will be appreciatedthat various modifications, permutations, additions and/orsub-combinations of these aspects and embodiments are possible. Suchmodifications, permutations, additions and/or sub-combinations areintended to be within the spirit and scope of the present invention asclaimed in the appended claims.

It will be understood that the invention may be embodied in otherspecific forms without departing from the spirit or centralcharacteristics thereof. The present examples and embodiments,therefore, are to be considered in all respects as illustrative and notrestrictive, and the invention is not to be limited to the details givenherein. Accordingly, while the specific embodiments have beenillustrated and described, numerous modifications come to mind withoutsignificantly departing from the spirit of the invention and the scopeof protection is only limited by the scope of the accompanying Claims.

1. A system for delivering a pharmaceutical product from a cartridge,comprising: an injector body having a side wall, said side wall having aproximal end portion, a distal end portion, an inner surface and anouter surface, said inner surface of said side wall defining a cavityfor receiving at least a portion of said cartridge; a plunger rod havinga proximal end portion and a distal end portion; one or more retentionmembers disposed on one of said outer surface of said injector body andan outer surface of said plunger rod, the other of said injector bodyand said plunger rod having one or more receiving members adapted toengage said retention members; and, a tamper-evident band having a firstportion secured to said injector body and a second portion secured tosaid plunger rod.
 2. The injector system of claim 1, wherein one of saidfirst portion and said second portion of said tamper-evident band has afrangible portion that fractures upon certain movement of said plungerrod with respect to said injector body.
 3. The injector system of claim1, wherein said tamper-evident band has a distinct color different fromsaid injector body and said plunger rod to provide a visual indicatorupon fracture to a user.
 4. The injector system of claim 1, wherein saidone or more retention members and said one or more receiving members areconstructed to cooperatively retain said plunger rod to said injectorbody adjacent said outer surface of said injector body when said plungerrod is in a first position, said one or more retention members and saidone or more receiving members constructed to cooperatively release saidplunger rod from said injector body when said plunger rod istransitioned axially toward said distal end of said injector body to asecond position.
 5. The injector system of claim 1, wherein said one ormore retention members are disposed on said outer surface of saidinjector body, and wherein said one or more receiving members areprovided in said plunger rod between said proximal end and said distalend thereof.
 6. The injector system of claim 1, wherein a portion ofsaid one or more retention members proximal said outer surface of saidinjector body have a narrower cross-sectional width than across-sectional width of a portion of said retention member distal saidouter surface of said injector body to define a dovetail-typeconfiguration.
 7. The injector system of claim 5, wherein said one ormore receiving members comprise a cavity having a mating configurationto said retaining members.
 8. The injector system of claim 1, whereinsaid plunger rod further has a pushing surface for engaging saidcartridge positioned within said cavity of said injector body, saidpushing surface constructed to move said cartridge body axially distallyas said plunger rod is moved from said first position to said secondposition, whereby movement of said plunger rod from said first positionto said second position releases said plunger rod from said injectorbody, and whereby movement of said plunger rod from said first positionto said second position simultaneously activates said pharmaceuticalcartridge.
 9. The injector system of claim 1, wherein said pushingsurface has an exterior flange extending transversely therefrom todefine a cavity for receiving a proximal end of said cartridge, saidpushing surface with said flange cooperating to preclude access to agrommet at a proximal end of said cartridge.
 10. The injector system ofclaim 1, wherein said distal end portion of said plunger rod has aconnection member constructed to attach to a connecting memberassociated with a piston of said pharmaceutical cartridge.
 11. Theinjector system of claim 10, wherein said connection member of saidplunger rod has threads formed thereon whereby said plunger rod can bethreadably secured to a connecting member mounted on a piston associatedwith the cartridge.
 12. The injector system of claim 1, furthercomprising a hinge clip hingably connected to said injector body, saidhinge clip being hingably moveable from a first position wherein amajority of said hinge clip is outside of said cavity of said injectorbody, and a second position wherein a portion of said hinge clip isinside said cavity of said injector body to laterally retain a hubconnected to said cartridge.
 13. The system of claim 12, wherein saidhinge clip is connected to said injector body in both said first andsecond positions.
 14. The system of claim 12, wherein said hinge cliphas projections that extend through openings in the side wall of theinjector body to engage the hub to prevent axial and radial movement ofthe hub.
 15. A system for delivering a pharmaceutical product from acartridge, comprising: an injector body having a side wall having aproximal end portion and a distal end portion, said side wall having aninner surface and an outer surface, said inner surface of said side walldefining a cavity for receiving at least a portion of said cartridge; aplunger rod having a proximal end portion and a distal end portion; and,a retention member disposed on one of said outer surface of saidsidewall of said injector body and an outer surface of said plunger rod,the other of said injector body and said plunger rod having a receivingmember adapted to engage said retention member, wherein cooperation ofsaid retention member and said receiving member precludes radial androtational movement of the plunger rod when the plunger rod is connectedadjacent the sidewall of the injector body, and wherein said cooperationof said retention member and said receiving member allows axial movementof said plunger rod with respect to said injector body to release saidplunger rod from said injector body.
 16. The injector system of claim15, wherein a portion of said retention member proximal said outersurface of said injector body has a narrower cross-sectional width thana cross-sectional width of a portion of said retention member distalsaid outer surface of said injector body to define a dovetail-typeconfiguration, and wherein said receiving member comprises a cavityhaving a mating configuration to said retaining member.
 17. The injectorsystem of claim 15, wherein said retention member extends from saidinjector body, and wherein said plunger rod contains said receivingmember.
 18. The injector system of claim 15, further comprising atamper-evident band having a first portion secured to the injector bodyand a second portion secured to the plunger rod.
 19. An injection systemfor delivering a pharmaceutical product from a cartridge, comprising: aninjector body having a side wall, said side wall having a proximal endportion, a distal end portion, an inner surface and an outer surface,said inner surface of said side wall defining a cavity for receiving atleast a portion of said cartridge, said injector body being made of afirst material; a plunger rod having a proximal end portion and a distalend portion, said plunger rod fixedly connected to said injector body ina first position, and said plunger rod being removable from saidinjector body in a second position, said plunger body being made of asecond material; and, a tamper-evident band having a first portionsecured to said injector body and a second portion secured to saidplunger rod, said tamper-evident band being made of a third material,wherein said first material, said second material and said thirdmaterial are different materials, and wherein said first material, saidsecond material and said third material preclude chemical and mechanicalbonding therebetween said materials.
 20. A method of manufacturing asystem for delivering a pharmaceutical product from a cartridge,comprising the steps of: molding an injector body having a side wallhaving a proximal end portion and a distal end portion, said side wallhaving an inner surface and an outer surface, said inner surface of saidside wall defining a cavity for receiving at least a portion of saidcartridge; molding a plunger rod on said injector body; molding a tamperevident band having a first portion connected to said injector body anda second portion connected to said plunger rod.
 21. The manufacturingmethod of claim 20, further comprising the step of molding a cliphingeably connected to said injector body.